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geneLEAD VIII PCR Reagent Cassette Set
EUDAMEDClass A (EU MDR)
Ref F8820Model geneLEAD PCR Reagent Cassette Set
Identity
- Trade Name
- geneLEAD VIII PCR Reagent Cassette Set EUDAMED
- Device Name
- geneLEAD VIII PCR Reagent Cassette Set EUDAMED
- Model / Reference
- geneLEAD PCR Reagent Cassette Set EUDAMEDF8820 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987869688203 EUDAMED
- Basic UDI-DI
- 4987869gLReagentWD EUDAMED
- EMDN Code
- W050301020202 SAMPLES ANALYSES, PLASTIC MICROTUBES WITHOUT ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Luxembourg 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 Reagent 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 | 4987869gLReagentWD | 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 cdc28e2b-7518-488f-8cf6-dbb7509772e2 61 fields · synced Aug 3, 2026