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geneLEAD VIII PCR Reaction Cassette Set
EUDAMEDClass A (EU MDR)
Ref F8840Model geneLEAD PCR Reaction Cassette Set
Identity
- Trade Name
- geneLEAD VIII PCR Reaction Cassette Set EUDAMED
- Device Name
- geneLEAD VIII PCR Reaction Cassette Set EUDAMED
- Model / Reference
- geneLEAD PCR Reaction Cassette Set EUDAMEDF8840 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987869688401 EUDAMED
- Basic UDI-DI
- 4987869gLRreactionP5 EUDAMED
- EMDN Code
- W050301020202 SAMPLES ANALYSES, PLASTIC MICROTUBES WITHOUT ADDITIVES 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
No
EUDAMED
New Device
No
EUDAMED
geneLEAD VIII PCR Reaction Cassette Set by Precision System Science Co., Ltd. — 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 | 4987869gLRreactionP5 | Class A | Active |
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Manufacturer
- Manufacturer
- Precision System Science Co., Ltd.
- EUDAMED SRN
- JP-MF-000029061
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 55167b43-c206-42c2-b50a-d7d7908ce7b4 61 fields · synced Jun 18, 2026