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Bowie-Dick Test Packs

EUDAMED

Class I (EU MDR)

Ref ST203Model ST201 ST203Ref ST201

by Nantong Ineuthink Medical Technology Co., Ltd

Identity

Device Name
Bowie-Dick Test Packs EUDAMED
Model / Reference
ST201 ST203 EUDAMED
ST203 EUDAMED
ST201 EUDAMED

Identifiers

Primary DI / UDI-DI
06978563510240 EUDAMED
06978563510806 EUDAMED
Basic UDI-DI
697856351BDTP01QW EUDAMED
EMDN Code
S0199 DEVICES FOR STERILISATION AND PACKAGING (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

Bowie-Dick Test Packs by Nantong Ineuthink Medical Technology 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-000047513
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED d388f5bd-8c19-400a-a58e-9784d51a909a 61 fields · synced Jul 20, 2026
  • EUDAMED 9a1368c6-fe48-448b-ab7c-479ea584c28e 61 fields · synced May 18, 2026