Identity
- Device Name
- DENTAL IMPLANTS - EXTERNA TINY EUDAMED
- Model / Reference
- IRTCA3010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435389812777 EUDAMED
- Basic UDI-DI
- 84353898IMPL-EXTTINYJV EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Implants - Externa Tiny by B.t.i. Biotechnology Institute, S.l — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84353898IMPL-EXTTINYJV | Class IIb | Active |
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Manufacturer
- Manufacturer
- B.t.i. Biotechnology Institute, S.l
- EUDAMED SRN
- ES-MF-000001701
Sources (1)
- EUDAMED ab04e3bc-1636-4029-9606-5e70cbeb9691 61 fields · synced Jun 18, 2026