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THERMOtec OPTIMUM CLEAR Bulk Pack 15 kg Base + 5kg Kat.
EUDAMEDClass IIa (EU MDR)
Ref 02530
by DETAX GmbH
Identity
- Trade Name
- THERMOtec OPTIMUM CLEAR Bulk Pack 15 kg Base + 5kg Kat. EUDAMED
- Device Name
- Thermotec EUDAMED
- Model / Reference
- 02530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET025301 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 OPTIMUM CLEAR Bulk Pack 15 kg Base + 5kg Kat. 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 a301a323-9d76-480a-a727-b01b42333565 61 fields · synced Jul 26, 2026