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Inflatable balloon

EUDAMED

Class I (EU MDR)

Ref 053.2Ref E3 1103PMRef 052.1Ref E3 31

by Wenzhou Bokang Instruments Co., Ltd

Identity

Trade Name
Inflatable balloon EUDAMED
Device Name
Inflatable balloon EUDAMED
Model / Reference
053.2 EUDAMED
E3 1103PM EUDAMED
052.1 EUDAMED
E3 31 EUDAMED

Identifiers

Primary DI / UDI-DI
06931038600235 EUDAMED
06931038600549 EUDAMED
06931038600242 EUDAMED
06931038600556 EUDAMED
Basic UDI-DI
69310386BULBRA EUDAMED
EMDN Code
A088001 PRESSURE INFUSION CUFFS, SINGLE-USE EUDAMED
Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
R030280 RESPIRATORY BALLONS - ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Poland EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Inflatable balloon by Wenzhou Bokang Instruments 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

Manufacturer
Wenzhou Bokang Instruments Co., Ltd
EUDAMED SRN
CN-MF-000021505
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 137bbeb6-b61c-4738-93b6-471011aa9cd1 61 fields · synced Jul 26, 2026
  • EUDAMED 5f93a3d8-7972-4ab3-b2a9-8134673a19fc 61 fields · synced May 17, 2026
  • EUDAMED 53e1a844-e061-4b94-80bb-0e5d9e11aec5 61 fields · synced May 18, 2026
  • EUDAMED b9ca847f-abdc-4030-8581-106c566e1d0d 61 fields · synced May 19, 2026