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Bm

EUDAMED

Class IIa (EU MDR)

Ref BM0603Model FR10

by Zhejiang Baite Medical Appliances Co., Ltd.

Identity

Trade Name
BM EUDAMED
Device Name
female nelaton catheter EUDAMED
Model / Reference
FR10 EUDAMED
BM0603 EUDAMED

Identifiers

Primary DI / UDI-DI
06974269381276 EUDAMED
Basic UDI-DI
B-06974269381276 EUDAMED
EMDN Code
U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Bm by Zhejiang Baite Medical Appliances Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000021983
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 26e96fd4-f807-4af1-bc08-7bd62bbe13f0 61 fields · synced Jun 18, 2026