Cozyhealth
EUDAMEDFDA UDIClass I (EU MDR)
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 EUDAMEDB08V959SX1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975866380051 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Cozyhealth by Chengdu Liangyue Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 0aff45d4-ee16-43f7-b2b3-009141754d0e 61 fields · synced May 30, 2026
- FDA UDI f5258c86-135a-4d9a-94c7-797cba5373de 32 fields · synced May 30, 2026