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Bowie-Dick Test Pack
EUDAMEDClass I (EU MDR)
Ref Bowie & Dick Test Pack I 12cmx13cmx16mmModel Bowie & Dick Test Pack I; Bowie & Dick Test Pack II
Identity
- Device Name
- BOWIE-DICK TEST PACK EUDAMED
- Model / Reference
- Bowie & Dick Test Pack I; Bowie & Dick Test Pack II EUDAMEDBowie & Dick Test Pack I 12cmx13cmx16mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974409690206 EUDAMED
- Basic UDI-DI
- 697440969BDTESTSM 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
Bowie-Dick Test Pack by Mediwish Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697440969BDTESTSM | Class I | Active |
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Manufacturer
- Manufacturer
- Mediwish Co., Ltd
- EUDAMED SRN
- CN-MF-000008849
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED be7cc2dc-50cd-430f-a7c1-72f9b5383ad1 61 fields · synced Jul 21, 2026