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TMB Soluble Reagent (Standard Sensitivity) 125 mL
EUDAMEDClass A (EU MDR)
Ref TM1125
Identity
- Trade Name
- TMB Soluble Reagent (Standard Sensitivity) 125 mL EUDAMED
- Device Name
- Histology Reagents - Other EUDAMED
- Model / Reference
- TM1125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108718857 EUDAMED
- Basic UDI-DI
- 081010871W01030799GD EUDAMED
- Direct Marketing DI
- 00810108718857 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER 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
TMB Soluble Reagent (Standard Sensitivity) 125 mL 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 | 081010871W01030799GD | 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 (1)
- EUDAMED 456cd9cf-cf9c-47c9-a934-6ce6d82d9aa9 61 fields · synced Sep 18, 2026