Identity
- Trade Name
- NiTAN EUDAMED
- Device Name
- Stone Retrieval Device EUDAMED
- Model / Reference
- 48012457 EUDAMED48012462 EUDAMED48012459 EUDAMED48012456 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255605605648 EUDAMED04255605605747 EUDAMED04255605605686 EUDAMED04255605605624 EUDAMED
- Basic UDI-DI
- 42556056srd7T EUDAMED
- EMDN Code
- U090101 URINARY STONE RETRIEVAL BASKETS 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NiTAN by Epflex Feinwerktechnik 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 | 42556056srd7T | Class I | Active |
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Manufacturer
- Manufacturer
- EPflex Feinwerktechnik GmbH
- EUDAMED SRN
- DE-MF-000005425
Sources (4)
- EUDAMED 1c566ee0-131f-402b-8666-2ffc17048882 61 fields · synced Jul 30, 2026
- EUDAMED 6b0d1fef-be30-49bb-9754-64abf2b967d9 61 fields · synced May 18, 2026
- EUDAMED 78bc4608-71d5-44cb-82fd-e46dfe60c4ce 61 fields · synced May 18, 2026
- EUDAMED c3c04a30-9b05-4810-be83-5e3610522650 61 fields · synced May 18, 2026