Identity
- Trade Name
- EMAG® TIPS 1000µL EUDAMEDFDA UDI
- Generic Name
- Pipette tip IVD FDA UDI
- Device Name
- EMAG® TIPS 1000µL EUDAMEDSpecific tips for eMAG system which is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use FDA UDI
- Model / Reference
- 542568 EUDAMEDEMAG® TIPS 1000µL FDA UDI
- Description
- Specific tips for eMAG system which is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026615253 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000545TR EUDAMED
- Unit of Use DI
- 03573026615246 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050385 NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - 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
Emag® Tips 1000µl by Biomerieux Sa — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 357302BUDI000545TR | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (3)
- EUDAMED e168ff8e-2702-4a17-808f-2915725acddd 61 fields · synced Jun 18, 2026
- FDA UDI 61a96dfc-6e43-4eef-ae14-8b454a28d760 33 fields · synced May 30, 2026
- EUDAMED fd47a936-7397-46cc-90d9-350e31f7dcb3 61 fields · synced Jun 18, 2026