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One Step HRP Detection System, for 100 tests
EUDAMEDClass A (EU MDR)
Ref IHC-1DSHRP-T100
Identity
- Trade Name
- One Step HRP Detection System, for 100 tests EUDAMED
- Device Name
- Popratni reagensi za imunohistokemijsko bojenje EUDAMED
- Model / Reference
- IHC-1DSHRP-T100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892125502 EUDAMED
- Basic UDI-DI
- 385889212HPC30711AIHCMH EUDAMED
- Direct Marketing DI
- 03858892125502 EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
One Step HRP Detection System, for 100 tests by BioGnost Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: For Professional Use
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 | 385889212HPC30711AIHCMH | Class A | Active |
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Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED 2c9b3113-7899-431f-93f8-0260b5a6df66 61 fields · synced Jul 30, 2026