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Sterile Safety IV Catheter
EUDAMEDClass IIa (EU MDR)
Ref LZZModel Z model Pen-like
Identity
- Trade Name
- Sterile Safety IV Catheter EUDAMED
- Model / Reference
- Z model Pen-like EUDAMEDLZZ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951592142446 EUDAMED
- Basic UDI-DI
- 69515921FT4031HH EUDAMED
- EMDN Code
- C0101010102 PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, W/O INJECTION VALVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Safety IV Catheter by Beijing Fert Technology Co., Ltd. — Class IIa — 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 | 69515921FT4031HH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Fert Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009737
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED aad933be-1944-4f54-ab49-907eb823f7aa 61 fields · synced Jun 18, 2026