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tempofit regular A2 Muster
EUDAMEDClass IIa (EU MDR)
Ref 03534Model Colour variants
by DETAX GmbH
Identity
- Trade Name
- tempofit regular A2 Muster EUDAMED
- Model / Reference
- Colour variants EUDAMED03534 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET035341 EUDAMED
- Basic UDI-DI
- ++EDET08262 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
tempofit regular A2 Muster by DETAX GmbH & Co. KG — Class IIa — 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 | ++EDET08262 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DETAX GmbH
- EUDAMED SRN
- DE-MF-000022666
Sources (1)
- EUDAMED 6af48152-dced-4e14-a3a9-6dd77398ad91 61 fields · synced Jul 26, 2026