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THERMOtec ROSE Standard Pack 400g + 100g
EUDAMEDClass IIa (EU MDR)
Ref 02389
by DETAX GmbH
Identity
- Trade Name
- THERMOtec ROSE Standard Pack 400g + 100g EUDAMED
- Device Name
- Thermotec EUDAMED
- Model / Reference
- 02389 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET023891 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 Standard Pack 400g + 100g 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 5330a8a3-cd96-4e8e-a0c4-2d6750e36dab 61 fields · synced Jun 19, 2026