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nextaro® 20/20, 15 µm nominal
EUDAMEDFDA UDIClass I (EU MDR)
Ref 88353Model nextaro®
Identity
- Trade Name
- nextaro® 20/20, 15 µm nominal EUDAMEDnextaro® FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- nextaro® Transfer System (20/20 with 15 µm filter, nominal) FDA UDI
- Model / Reference
- nextaro® EUDAMED88353 EUDAMEDFDA UDI
- Description
- nextaro® Transfer System (20/20 with 15 µm filter, nominal) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04063574200012 EUDAMEDFDA UDI
- Basic UDI-DI
- 406357490017AH 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® 20/20, 15 µm nominal by SFM Medical Devices GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 406357490017AH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- sfm medical devices GmbH
- EUDAMED SRN
- DE-MF-000008166
Sources (2)
- EUDAMED 185aeb91-6b10-40bf-b539-ba565f89a6ab 61 fields · synced Jul 17, 2026
- FDA UDI 1d3d2786-f0e8-4488-a3d8-76e7336fc925 33 fields · synced May 30, 2026