Institut Straumann AG
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000009933 FEI 3004975279
Institut Straumann AG is a medical device manufacturer based in Switzerland, with 5,202 devices listed as of 14 Nov 2026.
- Devices
- 5,202
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 2,961
- EUDAMED 2,558
- FDA 510(k) 4
- Device classes
- EU Class IIb 1,367
- FDA Class I 752
- EU Class IIa 459
- FDA Class II 416
- EU Class I 5
- FDA Class III 1
- Top EMDN categories
- Sites and related companies
- Etkon GmbH authorised representative
- Identifiers
- EUDAMED SRN CH-MF-000009933
- FDA FEI 3004975279
- DUNS 483599259
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
- Authorised rep.
- Etkon GmbHDE
What Institut Straumann AG makes
Institut Straumann AG manufactures dental implants and associated components, including the Straumann® Falcon system for guided implant placement, custom abutments (e.g., Neodent Gold Hue and Medentika Gold Hue), and various implant types such as the BLT and TL implants. Their portfolio also includes ceramic implants, temporary and final abutments (e.g., Variobase, SynOcta, and cementable designs), and surgical tools like the Dynamic Navigation system and edentulous trays for implant frameworks. Additional items include non-sterile temporary abutments and final copings for specific implant systems.
The company’s devices are classified under EU regulations as Class II, Class IIa, Class IIb, and Unclassified (U), with corresponding listings in the EUDAMED database and FDA’s 510(k) registry. Institut Straumann AG is headquartered in Switzerland.
Catalogue
Search and filter all 5,202 devicesShowing 1-50 of 5,202
Company details
- EUDAMED SRN
- CH-MF-000009933
- FDA FEI number
- 3004975279
- DUNS number
- 483599259
- EU VAT number
- CHE-113.320.319
- EUDAMED status
- Active
- EUDAMED registered name
- Institut Straumann AG
- EUDAMED abbreviated name
- Straumann
- Registered address
- 12, Peter Merian-Weg, 4002, Basel, Switzerland
- Website
- www.straumann.com
- info@straumann.com
- Phone
- +41 61 965 11 11
- PRRC contact
- Claire Gourichon
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 25 May 2030
TÜV SÜD Product Service GmbH 0123 2 certificates
- G10 020326 0062 Active
Quality management system EU MDR
- Issued
- 4 Jun 2025
- Expires
- 15 Jun 2030
- Valid from
- 16 Jun 2025
- G11 020326 0063 Active
Quality management system EU MDR
- Issued
- 23 May 2025
- Expires
- 25 May 2030
- Valid from
- 26 May 2025
Frequently asked questions
How many devices does Institut Straumann AG have in the registry?
The registry currently lists 5202 devices for Institut Straumann AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Institut Straumann AG's devices?
Among its 50 most recently registered devices, Institut Straumann AG has devices listed in EUDAMED (33 devices) and FDA GUDID (37 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Institut Straumann AG's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Institut Straumann AG's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Institut Straumann AG?
EUDAMED lists 2 certificates for Institut Straumann AG (quality management system) under MDR. The most recent was issued on 4 Jun 2025.
What are the newest devices from Institut Straumann AG in the registry?
The most recently registered devices listed for Institut Straumann AG include ProClean Cassette, Surgically Invasive Instruments: Drill / Tap, Surgically Invasive Instruments: iGuide Instruments and Novaloc Abutment.