Identity
- Trade Name
- Scalpel Handle Angled No. 4XL EUDAMED
- Device Name
- Reusable, Stainless Steel, Non-Sterile Surgical Knives and Scalpel Handles EUDAMED
- Model / Reference
- RD-136-35R EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G072RD13635R0M EUDAMED
- Basic UDI-DI
- ++G072RUKNIVESSCALPELS9E EUDAMED
- Direct Marketing DI
- +G072RD13635R0M EUDAMED
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Scalpel Handle Angled No. 4XL 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 | ++G072RUKNIVESSCALPELS9E | 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 aeab1166-e7a3-4000-b2ee-32d527d4f479 61 fields · synced Oct 5, 2026