Identity
- Trade Name
- Hot or cold pack for Eye mask EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMED
- Model / Reference
- AMRD01 EUDAMEDBGYZ07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978920971554 EUDAMED
- Basic UDI-DI
- 697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06978920971554 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
Category: Hot/cold therapy pack, reusable
Hot or cold pack for Eye mask by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 4162d2f3-ac38-4719-a9e6-a62d53fd366b 61 fields · synced Jun 11, 2026