5 documents · original texts

Certificates and declarations of conformity

The Active3® Erection System is a Class IIa medical device documented under European Union medical device legislation. The five documents below cover the device's CE declaration of conformity, the manufacturer's quality system certificates and its MDR transition status; each is published in the original, with an English rendering of the German passages.

Device class: Class IIa medical device
CE notified body: mdc medical device certification GmbH · 0483
Basic UDI-DI: 04013273001915
UMDNS: 17-744
Manufacturer SRN: DE-MF-000013106
Quality system: EN ISO 13485:2016

About translation and validity

The original documents are issued in English and German. The English rendering shown next to the German passages is not an official translation; it is an informational translation prepared to make the document understandable, and only the original text is legally binding. Some of the certificates remain valid beyond the date printed on them because of the European Union's MDR transition timetable — the basis for this is the notified body confirmation letter below.

014 February 2020 – 26 May 2024 (extended by the MDR transition letter)

CE declaration of conformity for Active3 (Class IIa)

Konformitätserklärung / Declaration of Conformity — AES 3

The document belonging to the very device presented on this site. The manufacturer declares that the Active3 Erection System is a Class IIa medical device under the Annex IX classification criteria of Medical Device Directive 93/42/EEC, and that the conformity assessment was completed under notified-body supervision. The intended purpose is stated in the document as "vacuum erection device for erectile dysfunction" — this is the device's official indication.

Issued by: KESSEL medintim GmbH · Notified body: mdc medical device certification GmbH (CE 0483)
Scope: Active 3 Erection System · Article no. AES 3 · Basic-UDI 04013273001915
Document no.: Konformitätserklärung AES3 · 001/04.02.2020 · UMDNS 17-744
Validity: 4 February 2020 – 26 May 2024 (extended by the MDR transition letter)

Original text · German (bilingual with English)

English translation

nach Anhang V der Richtlinie 93/42/EWG über Medizinprodukte — according to Annex V MDD 93/42/EEC concerning medical devices

According to Annex V of Directive 93/42/EEC concerning medical devices

Wir, KESSEL medintim GmbH, erklären in alleiniger Verantwortung, dass für das nachstehende Medizinprodukt ein Konformitätsbewertungsverfahren nach Anhang V in Verbindung mit Anhang VII der Richtlinie über Medizinprodukte 93/42/EWG durchgeführt wurde und dieses den einschlägigen Bestimmungen für Medizinprodukte der Klasse IIa gemäß Anhang IX Klassifizierungskriterien, der Regel 9 entspricht.

We, KESSEL medintim GmbH, declare under our sole responsibility that a conformity assessment procedure in accordance with Annex V in conjunction with Annex VII of the Medical Device Directive 93/42/EEC has been carried out for the medical device below, and that it complies with the relevant provisions for Class IIa medical devices pursuant to Rule 9 of the Annex IX classification criteria.

Bezeichnung / Description: Active 3 Erection System — Artikel Nr.: AES 3

Description: Active 3 Erection System — Article no.: AES 3

Zweckbestimmung / Intended purpose: Vakuumerektionshilfe bei erektiler Dysfunktion — Vacuum erection device for erectile dysfunction

Intended purpose: Vacuum erection aid for erectile dysfunction

Benannte Stelle / Notified Body: mdc medical device certification GmbH, Kriegerstraße 6, 70191 Stuttgart — Kennnummer: CE 0483

Notified body: mdc medical device certification GmbH, Kriegerstraße 6, 70191 Stuttgart — Identification number: CE 0483

Quoted section: Declaration text and particulars. The original is reproduced verbatim from the document; the English rendering is an informational translation.

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0224 June 2019 – 26 May 2024 (extended by the MDR transition letter)

EC certificate — manufacture of vacuum erection devices

EC Certificate — Vacuum Erection Devices

The audit document behind the CE declaration of conformity. The notified body audited the quality system the manufacturer operates for the production of vacuum erection devices and certified that it meets the requirements of Annex V, Section 3 of Directive 93/42/EEC. The declaration of conformity above rests on this certificate; the two are read together.

Issued by: mdc medical device certification GmbH · Notified body 0483
Scope: KESSEL medintim GmbH · Scope: vacuum erection devices
Document no.: Registration no. D1141600013 · Report no. P19-00154-138532
Validity: 24 June 2019 – 26 May 2024 (extended by the MDR transition letter)

Original text · English

mdc medical device certification GmbH, Notified Body 0483, herewith certifies that KESSEL medintim GmbH, Kelsterbacher Straße 28, 64546 Mörfelden-Walldorf, Germany, for the scope Vacuum Erection Devices has introduced and applies a Quality System for the manufacture of the products concerned and carries out a final inspection as specified in Annex V, Section 3.

The mdc audit has proven that this quality system meets all requirements according to Annex V – Section 3 of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

The surveillance will be held as specified in Annex V, Section 4.

Valid from 2019-06-24 · Valid until 2024-05-26 · Registration no. D1141600013

Quoted section: Certificate text. Reproduced verbatim from the original document.

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03Issued 28 May 2024 · Transition period: 31 December 2028

MDR transition confirmation letter — including Active3

Notified Body Confirmation Letter — Registration no. D1141600022

The document explaining why the 26 May 2024 date printed on the two documents above does not mean the device has been withdrawn from the market. When the European Union moved its medical device legislation from the MDD directive to the MDR regulation, it granted a transition timetable through Regulation (EU) 2023/607. This letter confirms that the manufacturer has applied under the MDR, has signed a written agreement with the notified body, and that surveillance continues. The Active Erection System is named explicitly as a Class IIa device in Table 1 of the letter; for Class IIa devices the transition period runs until 31 December 2028.

Issued by: mdc medical device certification GmbH · Notified body 0483
Scope: KESSEL medintim GmbH (SRN: DE-MF-000013106) · Active Erection System, Basic UDI-DI 4013273001915, Class IIa
Document no.: Registration no. D1141600022 · ID 10846 / 002/12.2023
Validity: Issued 28 May 2024 · Transition period: 31 December 2028

Original text · English

This letter confirms that mdc medical device certification GmbH, a Notified Body designated against Regulation (EU) 2017/745 (MDR) and identified by the number 0483 on NANDO, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the following manufacturer: KESSEL medintim GmbH.

Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive: Active Erection System (Basic UDI-DI: 4013273001915) — Class IIa — Certificate Registration no. #D1141600013; NB 0483.

31 December 2028 for other Class IIb devices, Class IIa, Class I devices placed on the market in sterile condition or have a measuring function.

Quoted section: Confirmation text and transition timetable. Reproduced verbatim from the original document.

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0415 May 2023 – 31 March 2025

EN ISO 13485 quality management system certificate

Certificate — Quality Management System EN ISO 13485

A certificate belonging to the manufacturer itself rather than to the product. ISO 13485 is the quality management standard of the medical device industry: it requires processes — from design to production, from traceability to complaint handling — to be run in a documented way. The scope line of the certificate defines the manufacturer's field of activity as "medical devices for contraception and sexual health care" — showing that the device is not an incidental by-product but the company's core area of expertise.

Issued by: mdc medical device certification GmbH · Accreditation: DAkkS D-ZM-16002-06-00
Scope: KESSEL medintim GmbH · Scope: development, manufacture and distribution of medical devices for contraception and sexual health care
Document no.: Registration no. D1141600020 · Report no. P22-00932-238993 · EN ISO 13485:2016 + AC:2018 + A11:2021
Validity: 15 May 2023 – 31 March 2025

Original text · English

mdc medical device certification GmbH certifies that KESSEL medintim GmbH, Kelsterbacher Straße 28, 64546 Mörfelden-Walldorf, Germany, for the scope Development, manufacture, and distribution of medical devices for contraception and sexual health care has introduced and applies a Quality Management System.

The mdc audit has proven that this quality management system meets all requirements of the following standard: EN ISO 13485 — Medical devices – Quality management systems – Requirements for regulatory purposes.

EN ISO 13485:2016 + AC:2018 + A11:2021 - ISO 13485:2016

Valid from 2023-05-15 · Valid until 2025-03-31 · Registration no. D1141600020

Quoted section: Certificate text. Reproduced verbatim from the original document.

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05Issued 5 November 2021

MDR declaration of conformity for the manual model (MES 01)

EU Declaration of Conformity — Manual Erection System, MES 01

The declaration for the same manufacturer's hand-pumped model. We include it for two reasons: first, the pump heads and cylinders of the two models are interchangeable; second, it shows that the manufacturer also issues declarations under the new MDR (EU) 2017/745 regulation. Because the manual model contains no motor, it is classified as Class I and requires no notified-body involvement — which is why the electric Active3 is Class IIa.

Issued by: KESSEL medintim GmbH · No notified body required (Class I)
Scope: Manual Erection System · Article no. MES 01 · Basic-UDI-DI 4013273MESREHM9 · SRN DE-MF-000013106
Document no.: FB017_02 Vorlage Konformitätserklärung Rev.007/05.11.2021 · UMDNS 17-744
Validity: Issued 5 November 2021

Original text · English

We, Kessel medintim GmbH, declare our sole responsibility, that the product listed below is covered by present declaration as a Medical Device. The product is classified as a Class I device in accordance with European Medical Device Regulation (EU) 2017/745 [MDR] Rule 1 of Annex VIII.

The product has been evaluated to Conformity Assessment Procedure of the MDR Annex II, Annex III and Article 19 and it conforms to the related General Safety and Performance Requirements of the MDR Annex I.

Trade Name: Manual Erection System — Article No. MES 01 — Intended purpose: Manual Vacuum Erection Device for erectile dysfunction

Medical device risk class: Class I (non-sterile, non-measurement) — Notified body: not required — Issue date: 5 November, 21

Quoted section: Declaration text and particulars. Reproduced verbatim from the original document.

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What does Class IIa mean?

What the documents guarantee — and what they do not

The European Union classifies medical devices according to the risk they carry. Class I is the lowest-risk group and can be placed on the market on the manufacturer’s own declaration; for Class IIa, an independent notified body steps in — it audits the manufacturer’s quality system, reviews the technical file and maintains ongoing surveillance. Active3 is Class IIa because of its motorised pump head; the same manufacturer’s manually pumped model is classified as Class I.

These documents show that the device meets safety and performance requirements and is manufactured under a traceable quality system. They do not show who it will be effective for — that question belongs not to the documents but to clinical assessment and a medical examination.

Clinical evidence for the method

The documents show regulatory compliance; whether the method works is a separate question. Five peer-reviewed papers on vacuum erection therapy — including a meta-analysis — are on a separate page, with their original texts.

Go to the clinical research

Technical specifications

Cylinder dimensions, ring diameters, maximum vacuum, battery and the IEC 60601 standards the device complies with are listed in the specifications table on the product page.

Go to the product page

Info & order

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