Identity
- Trade Name
- NUCLISENS® easyMAG® Disposables EUDAMEDFDA UDI
- Generic Name
- Pipette tip IVD FDA UDI
- Device Name
- NUCLISENS® easyMAG® Disposables EUDAMEDNUCLISENS EASYMAG DISPOSABLE are intended to be used with NucliSENS easyMAG. FDA UDI
- Model / Reference
- 542632 EUDAMEDNUCLISENS® easyMAG® Disposables FDA UDI
- Description
- NUCLISENS EASYMAG DISPOSABLE are intended to be used with NucliSENS easyMAG. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026616618 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000508TK EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES EUDAMED
- GMDN Term
- Pipette tip IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pipette tip IVD
NUCLISENS® easyMAG® Disposables by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 4f976ffe-79a6-4601-8708-7713937426bc 34 fields · synced Jul 23, 2026
- EUDAMED c95373f4-181a-4652-83f8-f3553c16addb 61 fields · synced Jul 23, 2026