Identity
- Device Name
- Blanket Warming Units EUDAMED
- Model / Reference
- 85000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181643578 EUDAMED
- Basic UDI-DI
- B-06973181643578 EUDAMED
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Blanket Warming Units by Dongguan Kaiser Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973181643578 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan Kaiser Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000006968
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED f3b648ef-ebde-4f8b-962c-230b9c234ac5 61 fields · synced Jul 9, 2026