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Heated Eye Mask
EUDAMEDClass I (EU MDR)
Ref /Model BIYZ10Model C502B0Model AMRD01
Identity
- Trade Name
- Heated Eye Mask EUDAMED
- Device Name
- Heated Eye Mask EUDAMEDReusable Hot/cold packs EUDAMED
- Model / Reference
- BIYZ10 EUDAMED/ EUDAMEDC502B0 EUDAMEDAMRD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589091636 EUDAMED06978920971851 EUDAMED
- Basic UDI-DI
- B-06973589091636 EUDAMED697358909HP100MD EUDAMED697892097HP100Q6 EUDAMED
- Direct Marketing DI
- 06973589091636 EUDAMED06978920971851 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
Heated Eye Mask by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06973589091636 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973589091636 | 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 (3)
- EUDAMED f72d90ec-89f7-4c24-b613-3b58a5ebf976 61 fields · synced Jul 23, 2026
- EUDAMED d4ed4ffc-99c3-4745-94b8-6144b1d55479 61 fields · synced May 19, 2026
- EUDAMED e1ce7ff1-33c2-4079-824b-12ee6494645a 61 fields · synced Jul 23, 2026