Identity
- Trade Name
- SOFT NECK COLLAR EUDAMED
- Device Name
- SOFT NECK COLLAR EUDAMED
- Model / Reference
- HEA382 S-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976057823425 EUDAMED
- Basic UDI-DI
- 69760578231YM EUDAMED
- EMDN Code
- M030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE 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
Soft Neck Collar by Ningbo Unico Products 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 | 69760578231YM | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Unico Products Co., Ltd
- EUDAMED SRN
- CN-MF-000039604
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 5d289213-ffc2-4315-a0e5-1d489b579a4d 61 fields · synced Jul 18, 2026