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THERMOtec ROSE Big Pack 800g + 200g
EUDAMEDClass IIa (EU MDR)
Ref 02337
by DETAX GmbH
Identity
- Trade Name
- THERMOtec ROSE Big Pack 800g + 200g EUDAMED
- Device Name
- Thermotec EUDAMED
- Model / Reference
- 02337 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET023371 EUDAMED
- Basic UDI-DI
- ++EDET0405J EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER 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
THERMOtec ROSE Big Pack 800g + 200g 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 | ++EDET0405J | Class IIa | Active |
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Manufacturer
- Manufacturer
- DETAX GmbH
- EUDAMED SRN
- DE-MF-000022666
Sources (1)
- EUDAMED 5d0203a5-367d-4fc3-94f3-eb7eabc503fd 61 fields · synced Jul 29, 2026