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Romo Vac Set
EUDAMEDClass IIa (EU MDR)
Ref GS-5002MRef GS-5002FRef GS-5002SRef GS-5002N
Identity
- Trade Name
- ROMO VAC SET EUDAMED
- Device Name
- Closed Wound Drainage System EUDAMED
- Model / Reference
- GS-5002M EUDAMEDGS-5002F EUDAMEDGS-5002S EUDAMEDGS-5002N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120500205 EUDAMED08902120500274 EUDAMED08902120500328 EUDAMED08902120500250 EUDAMED08902120500212 EUDAMED08902120500335 EUDAMED08902120500106 EUDAMED08902120500359 EUDAMED
- Basic UDI-DI
- 8902120G001SJ EUDAMED
- EMDN Code
- A0601010103 BELLOWS DRAINAGE SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDTürkiye 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 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 | 8902120G001SJ | 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 036f5f54-39d9-48ce-91b1-a7d7702e0cd1 61 fields · synced Oct 5, 2026
- EUDAMED fe4d29dd-0a97-4584-b1c7-676ae833c03a 61 fields · synced May 16, 2026
- EUDAMED 2d329563-05a2-4321-91c9-04d4d69a527e 61 fields · synced May 16, 2026
- EUDAMED c74dbd0b-f16d-43d8-8688-7017eb7ede6d 61 fields · synced May 17, 2026
- EUDAMED 7934c05b-53f2-4ee4-bb6e-46b08b80e452 61 fields · synced May 17, 2026
- EUDAMED 65881819-a9ff-4d2a-9728-54ee3ca1117f 61 fields · synced May 18, 2026
- EUDAMED 5009779d-ed72-4733-92d8-543c53bcf800 61 fields · synced May 18, 2026
- EUDAMED 360fdaca-1cc1-4604-bd1a-ee17e09ff8fb 61 fields · synced May 19, 2026