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Universal, HRP Polymer Detection System 1 Kit(s)
EUDAMEDClass A (EU MDR)
Ref UPK100Ref UPK008Ref UPK005
Identity
- Trade Name
- Universal, HRP Polymer Detection System 1 Kit(s) EUDAMED
- Device Name
- Immunohistology Kits EUDAMED
- Model / Reference
- UPK100 EUDAMEDUPK008 EUDAMEDUPK005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108719458 EUDAMED00810108719441 EUDAMED00810108719434 EUDAMED
- Basic UDI-DI
- 081010871W01030711F5 EUDAMED
- Direct Marketing DI
- 00810108719458 EUDAMED00810108719441 EUDAMED00810108719434 EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
Classification
- Device Class
- Class A 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
Universal, HRP Polymer Detection System 1 Kit(s) by ScyTek Laboratories Inc. — Class A — 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 | 081010871W01030711F5 | Class A | Active |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 034c77b4-4e78-4d56-97e3-69ef38f0a8df 61 fields · synced Jul 9, 2026
- EUDAMED f830f02e-dd30-41c7-93a1-fa941932034a 61 fields · synced May 17, 2026
- EUDAMED 4a2cd363-acea-45a9-a3f1-eadd53aee68e 61 fields · synced May 18, 2026