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Cozyhealth
EUDAMEDFDA UDIClass I (EU MDR)
Ref B0BHYCC1SDModel B08V959SX1，B08Z3ZQS2B，B0BHYCC1SD ,or customized
Identity
- Trade Name
- Cozyhealth EUDAMEDFDA UDI
- Generic Name
- Cervical spine cushion FDA UDI
- Device Name
- Neck and Shoulder Relaxer EUDAMED
- Model / Reference
- B08V959SX1，B08Z3ZQS2B，B0BHYCC1SD ,or customized EUDAMEDB0BHYCC1SD EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975866380037 EUDAMEDFDA UDI
- Basic UDI-DI
- 697586638neck001BZ EUDAMED
- FDA Product Code
- IQK FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Cervical spine cushion FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cozyhealth by Chengdu Liangyue Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697586638neck001BZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Chengdu Liangyue Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000039100
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 5fb9cd48-3a72-4e8a-82b0-bba2ef9d1ba3 61 fields · synced Jun 20, 2026
- FDA UDI f5bd77cf-ef08-4985-99de-1aa031b9ec48 32 fields · synced May 30, 2026