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nextaro® v, 20/20, 5 μm
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 20040Model nextaro® v510(k) K240748
Identity
- Trade Name
- nextaro® v, 20/20, 5 μm EUDAMEDnextaro® v, 20/20, 5 µm FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- nextaro® v, 20/20 (with 5 µm filter) FDA UDI
- Model / Reference
- nextaro® v EUDAMED20040 EUDAMEDFDA UDI
- Description
- nextaro® v, 20/20 (with 5 µm filter) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04063574200401 EUDAMEDFDA UDI
- Basic UDI-DI
- 406357490019AM EUDAMED
- FDA Product Code
- LHI FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Medication transfer set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
nextaro® v, 20/20, 5 μm by SFM Medical Devices GmbH — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240748 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 406357490019AM | Class I | Active |
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Manufacturer
- Manufacturer
- sfm medical devices GmbH
- EUDAMED SRN
- DE-MF-000008166
Sources (3)
- EUDAMED 42f89565-4c75-4e86-b930-5c80993f3a44 85 fields · synced Jun 18, 2026
- FDA UDI a45cb7ce-3d61-486f-bdc4-7289e5108657 33 fields · synced May 30, 2026
- FDA 510(k) K240748 1 fields · synced May 18, 2026