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Bqs
EUDAMEDClass I (EU MDR)
Ref 053, 57mmx16mmModel 071, 072, 073, 053, 061, 063Ref 063
Identity
- Trade Name
- BQS EUDAMED
- Model / Reference
- 071, 072, 073, 053, 061, 063 EUDAMED053, 57mmx16mm EUDAMED063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977064120538 EUDAMED06977064120033 EUDAMED
- Basic UDI-DI
- 697706412PWPVB 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
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 | 697706412PWPVB | 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 (3)
- EUDAMED 9d828841-1645-454a-aaa1-90dc433e69c7 61 fields · synced Oct 6, 2026
- EUDAMED d5353ec7-f954-402b-b35f-3218fd63ff24 61 fields · synced May 18, 2026
- EUDAMED 9d828841-1645-454a-aaa1-90dc433e69c7-1 61 fields · synced Jun 10, 2026