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T-COR 8 Magnetic Mixer
EUDAMEDClass A (EU MDR)
Ref TC-5018-001Model Rev BRef TC-5049-001Model Rev D
Identity
- Trade Name
- T-COR 8 Magnetic Mixer EUDAMEDT-COR 8 EUDAMED
- Device Name
- T-COR 8 Magnetic Mixer EUDAMEDT-COR 8 EUDAMED
- Model / Reference
- Rev B EUDAMEDTC-5018-001 EUDAMEDRev D EUDAMEDTC-5049-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- None EUDAMEDNA EUDAMED
- Basic UDI-DI
- ++G143TC8MagneticMixerY5 EUDAMED++G143TC8RTPCRInstKF EUDAMED
- EMDN Code
- W02050180 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES EUDAMEDW02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE 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
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
T-COR 8 Magnetic Mixer 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 | ++G143TC8MagneticMixerY5 | 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 (2)
- EUDAMED 8a8bf281-4752-4bab-9342-0249d58e7185 61 fields · synced Aug 1, 2026
- EUDAMED 49ad2a82-695d-4687-8bef-d77b0800a340 61 fields · synced May 19, 2026