Identity
- Trade Name
- Dental Fixture EUDAMED
- Model / Reference
- BT3507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800034100002 EUDAMED
- Basic UDI-DI
- B-08800034100002 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Fixture by Kuwotech — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800034100002 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Kuwotech
- EUDAMED SRN
- KR-MF-000037478
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 0ea06aeb-4d57-4002-bcd9-5778e590d87e 61 fields · synced Jun 18, 2026