Identity
- Trade Name
- REDON DRAIN EUDAMEDREDON DRAIN WITHOUT NEEDLE EUDAMED
- Device Name
- Redon Drain Catheter with/without Needle EUDAMED
- Model / Reference
- GS-5004T EUDAMEDGS-5004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120500526 EUDAMED08902120500472 EUDAMED08902120500465 EUDAMED08902120500410 EUDAMED08902120500458 EUDAMED08902120500427 EUDAMED08902120500519 EUDAMED08902120500489 EUDAMED
- Basic UDI-DI
- 8902120G017SZ EUDAMED
- EMDN Code
- A060102 SURGICAL DRAINAGE CONNECTION MEDICAL TUBES 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
Category: Suction/irrigation tubing, single-use
Redon Drain by Romsons International (Unit II) — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Suction/irrigation tubing, single-use.
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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 | 8902120G017SZ | 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 0e184f50-d00c-4586-ab41-38d3685180ec 61 fields · synced Jul 31, 2026
- EUDAMED 99653428-a760-44e9-8c08-ae3c1a773886 61 fields · synced May 17, 2026
- EUDAMED a6ca2d8b-672c-4494-95f3-e71cd2e1a08a 61 fields · synced May 17, 2026
- EUDAMED 9e8847a5-aebe-4c5d-95de-22d051f621b1 61 fields · synced May 18, 2026
- EUDAMED 351873ae-9ddd-42c5-935d-2ca24c1332f0 61 fields · synced May 18, 2026
- EUDAMED 97c6388e-fe45-4a56-974d-cc7e64852ab3 61 fields · synced May 19, 2026
- EUDAMED e8dbf1ea-e2e0-46b0-907c-d4fdc82c5797 61 fields · synced May 19, 2026
- EUDAMED db22344a-87ea-4447-bbd6-ae992d1c220f 61 fields · synced May 19, 2026