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UltraTek Complete System - UltraTek Complete System
EUDAMEDClass A (EU MDR)
Ref UCS015Ref UCS125
Identity
- Trade Name
- UltraTek Complete System; Anti-Polyvalent, HRP, DAB 1 kit(s) EUDAMED
- Device Name
- Immunohistology Kits EUDAMED
- Model / Reference
- UCS015 EUDAMEDUCS125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108719151 EUDAMED00810108719168 EUDAMED
- Basic UDI-DI
- 081010871W01030711F5 EUDAMED
- Direct Marketing DI
- 00810108719151 EUDAMED00810108719168 EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
- Models / Variants
- UltraTek Complete System 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
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
UltraTek Complete System - UltraTek Complete System by ScyTek Laboratories Inc. — Class A — IVDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
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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 (2)
- EUDAMED a30a7869-883b-4c1a-b46c-7cbf2c5a5d98 61 fields · synced Jul 21, 2026
- EUDAMED d28492d0-010f-44f8-a0a8-cc4a75cb5256 61 fields · synced May 18, 2026