Identity
- Trade Name
- Dr. PCR 20K Cartridge -PF EUDAMED
- Device Name
- G_PCR Chip Case EUDAMED
- Model / Reference
- CTG01-04 EUDAMEDCTR002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809740940179 EUDAMED
- Basic UDI-DI
- 880974094ACC01EB EUDAMED
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
Dr. PCR 20K Cartridge -PF by OPTOLANE Technologies 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 | 880974094ACC01EB | Class A | Active |
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Manufacturer
- Manufacturer
- OPTOLANE Technologies Inc.
- EUDAMED SRN
- KR-MF-000026042
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED e33a9f36-e969-4133-ac0f-62d237c5492c 61 fields · synced Jun 18, 2026