Identity
- Trade Name
- CHEST DRAINAGE CATHETER EUDAMED
- Device Name
- Thoracic Drainage Catheter EUDAMED
- Model / Reference
- GS-5011 EUDAMEDGS-5010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120501158 EUDAMED08902120501141 EUDAMED08902120501059 EUDAMED08902120501073 EUDAMED08902120501042 EUDAMED08902120501110 EUDAMED08902120501097 EUDAMED08902120501028 EUDAMED08902120501172 EUDAMED
- Basic UDI-DI
- 8902120G003SN EUDAMED
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDBelgium 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
Chest Drainage Catheter by Romsons International (Unit II) — 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 | 8902120G003SN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (9)
- EUDAMED 635a23b5-935b-431c-83e9-ce50452f5ab4 61 fields · synced Jul 22, 2026
- EUDAMED 1e59f79d-47a8-4a20-a08d-e446f93466ed 61 fields · synced May 17, 2026
- EUDAMED 54cf4f73-6f61-4f16-909e-e43194d45b45 61 fields · synced May 17, 2026
- EUDAMED f4c88044-7ef7-4e02-89db-80f5009f4251 61 fields · synced May 17, 2026
- EUDAMED 7e5a4702-778c-4bfc-a36b-11f9f6cd939d 61 fields · synced May 17, 2026
- EUDAMED 0697d900-526e-499b-ae4a-62587c055c75 61 fields · synced May 19, 2026
- EUDAMED 1c01542e-84b4-470a-ad5c-e4f847a6419d 61 fields · synced May 19, 2026
- EUDAMED ad10896a-f2e9-4750-82aa-158bf2fd4dbc 61 fields · synced May 19, 2026
- EUDAMED a44b52e0-1c4a-4e13-acec-e5d42ecb53b7 61 fields · synced May 19, 2026