Identity
- Trade Name
- T-COR 8 Reaction Tube EUDAMED
- Device Name
- T-COR 8 Reaction Tube EUDAMED
- Model / Reference
- TC-5029-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- Not_app EUDAMED
- Basic UDI-DI
- ++G143TC8ReactionTubeWS EUDAMED
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
T-COR 8 Reaction Tube by Tetracore, 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 | ++G143TC8ReactionTubeWS | Class A | Active |
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Manufacturer
- Manufacturer
- Tetracore INC
- EUDAMED SRN
- US-MF-000023064
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 2a5a33fd-7cdf-4414-8a6c-4f9a3231390e 61 fields · synced Jul 14, 2026