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TestPack Plus hCG Urine with OBC
EUDAMEDClass IVD General (EU MDR)
Ref 505798JModel TestPack Plus hCG Urine with OBC
Identity
- Trade Name
- TestPack Plus hCG Urine with OBC EUDAMED
- Device Name
- TestPack Plus hCG Urine with OBC EUDAMED
- Model / Reference
- TestPack Plus hCG Urine with OBC EUDAMED505798J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571226471807 EUDAMED
- Basic UDI-DI
- B-04571226471807 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
TestPack Plus hCG Urine with OBC by Abbott Diagnostics Medical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04571226471807 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Abbott Diagnostics Medical Co., Ltd.
- EUDAMED SRN
- JP-MF-000009543
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 67f3b92b-8b23-4aa7-9430-6909a4cea829 61 fields · synced Jun 18, 2026