Identity
- Trade Name
- Opti-Soothe Mask EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMED
- Model / Reference
- AMRD01 EUDAMEDAKYZ03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920971103 EUDAMED
- Basic UDI-DI
- 697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920971103 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I 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
Opti-Soothe Mask by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — 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 | 697892097HP100Q6 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED df4fe16e-20c1-407f-a3f9-cdc80cd28205 61 fields · synced Jul 11, 2026