Identity
- Trade Name
- Temperature Control System EUDAMED
- Device Name
- Temperature Control System EUDAMED
- Model / Reference
- P6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021219 EUDAMED
- Basic UDI-DI
- B-06945429021219 EUDAMED
- EMDN Code
- Z1203020299,Z12040208 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Temperature Control System by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — 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-06945429021219 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 223e8df2-f286-4406-b536-86f9bc8032a6 61 fields · synced Jun 18, 2026