Identity
- Trade Name
- Nelaton Catheter EUDAMED
- Device Name
- Nelaton Catheter EUDAMED
- Model / Reference
- PU031212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310915410 EUDAMED
- Basic UDI-DI
- 69233109PU03PY EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Nelaton Catheter by Hangzhou Formed Medical Devices Co., Ltd. — 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 | 69233109PU03PY | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 652170d4-dc35-4484-aed8-ed06ffbd694d 61 fields · synced Jun 18, 2026