ALTATEC GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000006230 FEI 3002806355
- Devices
- 2,407
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 2 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
What ALTATEC GmbH makes
ALTATEC GmbH manufactures dental implant components and related products, including temporary and permanent implant suprastructure, implant analogs, laboratory abutment analogs, precision attachment tools, reusable steel dental burs, dental implant systems, and reusable surgical procedure kits.
The company's portfolio includes devices classified under Class I, Class II, Class IIa, and Class IIb, and is listed in regulatory registries including EUDAMED, FDA 510(k), and FDA UDI. ALTATEC GmbH is based in Germany.
Catalogue
Search and filter all 2,407 devicesShowing 1-50 of 2,407
Company details
- EUDAMED SRN
- DE-MF-000006230
- FDA FEI number
- 3002806355
- DUNS number
- 322018193
- EU VAT number
- DE147803270
- EUDAMED status
- Active
- EUDAMED registered name
- ALTATEC GmbH
- EUDAMED abbreviated name
- ALTATEC GmbH
- Registered address
- 5, Maybachstr., 71299, Wimsheim, Germany
- Website
- www.altatec.de
- Phone
- +49-70449445-311
- PRRC contact
- Raphael Brausch
EUDAMED certificates
2 certificates1 valid, 1 expiredMDR 2next expiry 24 Jun 2031
mdc medical device certification GmbH 0483 1 certificate
- D1063900002 Active
Quality management system EU MDR
- Issued
- 20 May 2026
- Expires
- 24 Jun 2031
- Valid from
- 25 Jun 2026
TÜV SÜD Product Service GmbH 0123 1 certificate
- G11 076870 0021 Expired
Quality management system EU MDR
- Issued
- 31 Aug 2022
- Expires
- 23 Jun 2026
- Reason
- Mnf ar change
Frequently asked questions
How many devices does ALTATEC GmbH have in the registry?
The registry currently lists 2407 devices for ALTATEC GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list ALTATEC GmbH's devices?
Among its 50 most recently registered devices, ALTATEC GmbH has devices listed in FDA GUDID (50 devices).
What risk classes do ALTATEC GmbH's devices fall under?
Among its 50 most recently registered devices, the classes recorded for ALTATEC GmbH's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ALTATEC GmbH?
EUDAMED lists 2 certificates for ALTATEC GmbH (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 20 May 2026.
What are the newest devices from ALTATEC GmbH in the registry?
The most recently registered devices listed for ALTATEC GmbH include Drill for CT-tube A2050.2600, Drill for CT-tube A2050.2800, Guide CONELOG® Insertion post C2026.3303 and Guide CONELOG® Insertion post C2026.3803.