Identity
- Trade Name
- Tofflemire Retainer EUDAMED
- Device Name
- Tofflemire Retainer EUDAMED
- Model / Reference
- tf105r EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003475598 EUDAMED
- Basic UDI-DI
- 08964003475TFRT13BZ EUDAMED
- EMDN Code
- L15901101 POSITIONING INSTRUMENTS FOR DENTAL MATRICES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Tofflemire Retainer by Jazbar International — Class I — 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 | 08964003475TFRT13BZ | Class I | Active |
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Manufacturer
- Manufacturer
- Jazbar International
- EUDAMED SRN
- PK-MF-000031447
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 8d0374b9-b4fb-44da-b9c3-3e3dc1c06648 61 fields · synced Jun 19, 2026