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Rapid Hp Star Lateral Flow Kit
EUDAMEDClass B (EU MDR)
Ref K671411-2
by Oxoid Ltd
Identity
- Trade Name
- RAPID HP STAR LATERAL FLOW KIT EUDAMED
- Device Name
- RAPID HP STAR LATERAL FLOW KIT EUDAMED
- Model / Reference
- K671411-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384171736 EUDAMED
- Basic UDI-DI
- 5032384RapIDHpStARE3 EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Rapid Hp Star Lateral Flow Kit by Oxoid Ltd — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5032384RapIDHpStARE3 | Class B | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED 52e0bad8-dd52-4757-9c88-afc52300e365 61 fields · synced Aug 2, 2026