Identity
- Trade Name
- SAFHandle EUDAMED
- Device Name
- Reusable Handle EUDAMED
- Model / Reference
- 00689-SAFh-4 EUDAMED00688-SAFh-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18903376006890 EUDAMED18903376006883 EUDAMED
- Basic UDI-DI
- 8903376RHX4 EUDAMED
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
SAFHandle by Razormed Inc. — 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 | 8903376RHX4 | Class I | Active |
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Manufacturer
- Manufacturer
- Razormed Inc.
- EUDAMED SRN
- IN-MF-000012812
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e718db61-6fd2-4f53-a036-c56325a57f57 61 fields · synced Jul 27, 2026
- EUDAMED 64e4e303-421d-4aff-ba55-69422c20f3e5 61 fields · synced May 19, 2026