Identity
- Trade Name
- NEL CATH EUDAMED
- Device Name
- NELATON CATHETER EUDAMED
- Model / Reference
- GS 1004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265100402 EUDAMED08907265100457 EUDAMED08907265100488 EUDAMED08907265100471 EUDAMED08907265100464 EUDAMED08907265100426 EUDAMED08907265100433 EUDAMED08907265100440 EUDAMED
- Basic UDI-DI
- 8907265A002Y5 EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Nel Cath by Romsons Group Private Limited — 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 | 8907265A002Y5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (8)
- EUDAMED 40a6fd52-90bd-4951-a231-646d15c91400 61 fields · synced Jul 27, 2026
- EUDAMED ecce88f9-59da-4596-aae7-8266e98effe9 61 fields · synced May 17, 2026
- EUDAMED a6ff8c87-1cf1-4fdd-beff-6bb398b21398 61 fields · synced May 17, 2026
- EUDAMED 6bcee008-5bef-4d42-ade9-3ba4c64c0ece 61 fields · synced May 18, 2026
- EUDAMED 06509ac3-33e1-499c-a26e-abbcba0481ed 61 fields · synced May 18, 2026
- EUDAMED 1357f2f0-7703-41fd-b68a-efa9c45c80c1 61 fields · synced May 19, 2026
- EUDAMED efadd89e-5200-4a6f-8099-4d5ff130651a 61 fields · synced May 19, 2026
- EUDAMED bd04b8ed-587a-4a0d-8afc-7d2c505f4878 61 fields · synced May 19, 2026