← Back to catalogue
geneLEAD VIII Consumable Set
EUDAMEDClass A (EU MDR)
Ref F8900Model geneLEAD Consumable Set
Identity
- Trade Name
- geneLEAD VIII Consumable Set EUDAMED
- Device Name
- geneLEAD VIII Consumable Set EUDAMED
- Model / Reference
- geneLEAD Consumable Set EUDAMEDF8900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987869689002 EUDAMED
- Basic UDI-DI
- 4987869gLConsumableG8 EUDAMED
- EMDN Code
- W0503020201 PIPETTE TIPS WITH FILTER 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 Consumable 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 | 4987869gLConsumableG8 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Precision System Science Co., Ltd.
- EUDAMED SRN
- JP-MF-000029061
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 35befdb2-005a-47eb-b970-846dc879e2c5 61 fields · synced Aug 1, 2026