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Disposable Bowie-Dick Test Pack

EUDAMED

Class I (EU MDR)

Ref HHR-BDBModel HHR-BDB, or customized

by Weihai Hengrui New Packaging Materials Co., Ltd.

Identity

Device Name
Disposable Bowie-Dick Test Pack EUDAMED
Model / Reference
HHR-BDB, or customized EUDAMED
HHR-BDB EUDAMED

Identifiers

Primary DI / UDI-DI
06978547570116 EUDAMED
Basic UDI-DI
697854757DBDTP1BDBZF EUDAMED
EMDN Code
S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Category: Sterilizer/disinfector rack

Disposable Bowie-Dick Test Pack by Weihai Hengrui New Packaging Materials Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Sterilizer/disinfector rack.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000050315
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED e964bea1-03ec-4f02-a786-4338a1c66f39 61 fields · synced Jun 19, 2026