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Bqs

EUDAMED

Class I (EU MDR)

Ref 061, 6cmx10cmModel 071, 072, 073, 053, 061, 063

by Changzhou Operson Medical Devices Co., Ltd

Identity

Trade Name
BQS EUDAMED
Model / Reference
071, 072, 073, 053, 061, 063 EUDAMED
061, 6cmx10cm EUDAMED

Identifiers

Primary DI / UDI-DI
06977064120613 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

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Manufacturer

EUDAMED SRN
CN-MF-000043215
Authorised Representative
BioDomi GmbH DE-AR-000016611

Sources (2)

  • EUDAMED edad8124-f232-4b87-80e4-50d93a03da37 61 fields · synced Jun 18, 2026
  • EUDAMED edad8124-f232-4b87-80e4-50d93a03da37-1 61 fields · synced Jun 10, 2026