Identity
- Trade Name
- SteriLance EUDAMED
- Device Name
- Safety Metal Handles EUDAMED
- Model / Reference
- 26-0203 Index Asurity3L# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630134842 EUDAMED
- Basic UDI-DI
- 6945630126BR EUDAMED
- Unit of Use DI
- 06945630134845 EUDAMED
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
SteriLance by Sterilance Medical (Suzhou) 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 | 6945630126BR | Class I | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4a884b13-579b-483c-8176-23f746ce7539 61 fields · synced May 23, 2026