Identity
- Trade Name
- InstruSafe EUDAMED
- Device Name
- InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers EUDAMED
- Model / Reference
- IN-2020-0906 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00385640017411 EUDAMED
- Basic UDI-DI
- 03856490146_INSTRUSAJP EUDAMED
- Direct Marketing DI
- 00385640017411 EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
InstruSafe by Summit Medical, LLC — 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 | 03856490146_INSTRUSAJP | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Summit Medical, LLC
- EUDAMED SRN
- US-MF-000026771
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4d2c238e-3538-4e21-b384-c07e6cb4a500 61 fields · synced May 23, 2026