Identity
- Trade Name
- BQS EUDAMED
- Model / Reference
- 815, 825, 855 EUDAMED855, 5cmx5m EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977064128558 EUDAMED
- Basic UDI-DI
- 697706412CT2P EUDAMED
- EMDN Code
- M050199 SURGICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
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 | 697706412CT2P | 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 709bc280-ef98-4e77-b472-ea766829ab3b 61 fields · synced Jun 18, 2026
- EUDAMED 709bc280-ef98-4e77-b472-ea766829ab3b-1 61 fields · synced Jun 10, 2026