Identity
- Trade Name
- THORACIC TROCAR CATHETER EUDAMED
- Device Name
- Thoracic Drainage Catheter EUDAMED
- Model / Reference
- GS-5030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120503091 EUDAMED08902120503121 EUDAMED08902120503008 EUDAMED08902120503077 EUDAMED08902120503084 EUDAMED08902120503053 EUDAMED08902120503046 EUDAMED08902120503039 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 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
Thoracic Trocar 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 (8)
- EUDAMED f1a99277-0de9-4165-8e4f-5ea89c0eb7a6 61 fields · synced Oct 6, 2026
- EUDAMED 56be8b50-b397-48e0-be06-2645af108aac 61 fields · synced May 16, 2026
- EUDAMED 1bbc53a0-a5f1-44f8-b766-6559922e372f 61 fields · synced May 19, 2026
- EUDAMED a3f8c213-5bf7-4ffd-9c3c-cd0d412a21c0 61 fields · synced May 19, 2026
- EUDAMED 479cf2bc-8733-412f-b6d5-ba55e113e8a8 61 fields · synced May 19, 2026
- EUDAMED 9f52ba7a-1af5-4c5e-be42-1b13f3e7497c 61 fields · synced May 19, 2026
- EUDAMED 2626cbb4-f7ad-4c37-810a-e73ce3ee764d 61 fields · synced May 19, 2026
- EUDAMED 5d31cbf9-4ba1-43ff-98a4-e0746234a496 61 fields · synced May 19, 2026