Identity
- Trade Name
- Kelly Proctoscopes, 21 mm Ø * 50 mm EUDAMED
- Device Name
- Reusable, Stainless Steel, Non-Sterile Surgical Retractors EUDAMED
- Model / Reference
- RAB-116-01R EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G072RAB11601R0L EUDAMED
- Basic UDI-DI
- ++G072RURETRACTORS6B EUDAMED
- Direct Marketing DI
- +G072RAB11601R0L EUDAMED
- EMDN Code
- L03140105 SKIN RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Kelly Proctoscopes, 21 mm Ø * 50 mm by Rhein Enterprises (Pvt) Ltd — Class I — 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 | ++G072RURETRACTORS6B | Class I | Active |
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Manufacturer
- Manufacturer
- Rhein Enterprises (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000036086
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 8f696f4d-c542-4b37-9ed3-ef8f2791b9d9 61 fields · synced Jun 20, 2026