Identity
- Trade Name
- nextaro® 32/32, 15 μm nominal EUDAMED
- Model / Reference
- nextaro® EUDAMED20036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04063574200364 EUDAMED
- Basic UDI-DI
- 406357490017AH EUDAMED
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
nextaro® 32/32, 15 μm nominal by SFM Medical Devices GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 406357490017AH | Class I | Active |
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Manufacturer
- Manufacturer
- sfm medical devices GmbH
- EUDAMED SRN
- DE-MF-000008166
Sources (1)
- EUDAMED 1d1a406b-8538-4447-9825-79be7579cec5 61 fields · synced Jul 26, 2026