Identity
- Device Name
- Comfy Blink Sleep Mask EUDAMED
- Model / Reference
- 343608 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979333852003 EUDAMED
- Basic UDI-DI
- 697933385mask001AV EUDAMED
- EMDN Code
- Y0999 PERSONAL CARE AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Comfy Blink Sleep Mask by Hangzhou Royal Craft Industrial 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 | 697933385mask001AV | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Royal Craft Industrial Co., LTD.
- EUDAMED SRN
- CN-MF-000050897
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED f2e33d77-3563-4f17-bcfc-037640c31774 61 fields · synced Jun 20, 2026