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Romo Vac Set
EUDAMEDClass IIa (EU MDR)
Ref GS-5002S KADRef GS-5002 SRef GS-5002 N KAD
Identity
- Trade Name
- ROMO VAC SET EUDAMED
- Device Name
- CLOSED WOUND DRAINAGE SYSTEM EUDAMED
- Model / Reference
- GS-5002S KAD EUDAMEDGS-5002 S EUDAMEDGS-5002 N KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265013092 EUDAMED08907265010152 EUDAMED08907265500219 EUDAMED08907265010145 EUDAMED08907265010183 EUDAMED08907265500226 EUDAMED08907265500202 EUDAMED08907265500257 EUDAMED08907265013351 EUDAMED
- Basic UDI-DI
- 8907265G001ZD EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR 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
Romo Vac Set 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 | 8907265G001ZD | 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 (9)
- EUDAMED f40661b6-672c-470b-9f48-33875c646349 61 fields · synced Aug 4, 2026
- EUDAMED cae8a7d9-91a8-493e-a01a-e5ffc578413c 61 fields · synced May 16, 2026
- EUDAMED 603c07ff-73f1-438d-9420-cc2660b93757 61 fields · synced May 16, 2026
- EUDAMED 471b4db6-0198-4196-a950-574e4707f732 61 fields · synced May 17, 2026
- EUDAMED 8f3b3856-9eee-4717-9296-275f1eb9d37b 61 fields · synced May 19, 2026
- EUDAMED 7b36f432-5950-43c4-a357-01c517e1ecb2 61 fields · synced May 19, 2026
- EUDAMED 471d22cf-b05a-44f7-aabf-b9a1429442e2 61 fields · synced May 19, 2026
- EUDAMED fd1024de-71d1-4c90-80ac-bdc4c2eef1b1 61 fields · synced May 19, 2026
- EUDAMED de73672a-ad91-4410-83ce-ef7a9d5ace27 61 fields · synced Aug 4, 2026