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magLEAD Consumable kit
EUDAMEDClass A (EU MDR)
Ref F4430Model magLEAD Consumable kit
Identity
- Trade Name
- magLEAD Consumable kit EUDAMED
- Device Name
- magLEAD Consumable kit EUDAMED
- Model / Reference
- magLEAD Consumable kit EUDAMEDF4430 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987869644308 EUDAMED
- Basic UDI-DI
- 4987869mLConsumableP6 EUDAMED
- EMDN Code
- W0503020201 PIPETTE TIPS WITH FILTER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
magLEAD Consumable kit 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 | 4987869mLConsumableP6 | 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 b7566cee-2286-4fd9-b95d-cd09579a44b4 61 fields · synced Jun 18, 2026