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Axiom
EUDAMEDClass IIb (EU MDR)
Ref TSHSB-R400Model Healing Screw (ZrN-coated Titanium)
by anthogyr
Identity
- Trade Name
- Axiom EUDAMED
- Model / Reference
- Healing Screw (ZrN-coated Titanium) EUDAMEDTSHSB-R400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03663394872287 EUDAMED
- Basic UDI-DI
- 36633940153R4 EUDAMED
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Axiom by anthogyr — 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 | 36633940153R4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- anthogyr
- EUDAMED SRN
- FR-MF-000000602
Sources (1)
- EUDAMED e0e20132-4daf-41c5-8b56-70ec3c89adef 61 fields · synced May 23, 2026