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Vulkan® External Hex. RP Implante 5.00x15
EUDAMEDClass IIb (EU MDR)
Ref EXT5015Model TICE
Identity
- Trade Name
- Vulkan® External Hex. RP Implante 5.00x15 EUDAMED
- Device Name
- Dental Implants External Hex Connection EUDAMED
- Model / Reference
- TICE EUDAMEDEXT5015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435539233476 EUDAMED
- Basic UDI-DI
- 84355392011TA 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
Vulkan® External Hex. RP Implante 5.00x15 by Titanimplant, 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 | 84355392011TA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Titanimplant, S.l.
- EUDAMED SRN
- ES-MF-000003263
Sources (1)
- EUDAMED e1352be4-6a8b-4fa3-b3a6-927fec1aecfd 61 fields · synced Jun 19, 2026