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Imagen Hsv Positive Control Slide
EUDAMEDClass C (EU MDR)
Ref S611030-2
by Oxoid Ltd
Identity
- Trade Name
- IMAGEN HSV POSITIVE CONTROL SLIDE EUDAMED
- Device Name
- IMAGEN HSV POSITIVE CONTROL SLIDE EUDAMED
- Model / Reference
- S611030-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384503049 EUDAMED
- Basic UDI-DI
- 5032384ImagenSlideHSVP2 EUDAMED
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Imagen Hsv Positive Control Slide by Oxoid Ltd — Class C — 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 | 5032384ImagenSlideHSVP2 | Class C | 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 060d6127-42d5-4bbd-8c40-bcc42bc03a94 61 fields · synced Jun 17, 2026