Identity
- Trade Name
- BQS EUDAMED
- Model / Reference
- 357 EUDAMED357, 5cmx7.5cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977064123577 EUDAMED
- Basic UDI-DI
- 697706412NWDU9 EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Bqs by Changzhou Operson Medical Devices 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 | 697706412NWDU9 | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Operson Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000043215
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (2)
- EUDAMED 774c2f3b-4eb0-4cd9-a5c4-f91052988a6e 61 fields · synced Oct 6, 2026
- EUDAMED 774c2f3b-4eb0-4cd9-a5c4-f91052988a6e-1 61 fields · synced Jun 10, 2026