InstruSafe
by Summit Medical, LLC 375 variants
Ref IN-2020-0648
InstruSafe (IN-2020-0648) is a Class I device made by Summit Medical, LLC, registered in EUDAMED on 27 May 2025 (Basic UDI-DI 03856490146_INSTRUSAJP), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number03856490146_INSTRUSAJP 00385640015400 | Date27 May 2025 | StatusActive |
Official records
- EUDAMED public site 03856490146_INSTRUSAJP
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers
- Model / reference
- IN-2020-0648
- Primary DI / UDI-DI
- 00385640015400
- Basic UDI-DI
- 03856490146_INSTRUSAJP
- Direct marketing DI
- 00385640015400
- EMDN code
- V0402 Clinical use trays and bowls
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000026771
- Authorised representative
- MDSS GmbH DE-AR-000005430
Similar devices in this category
Other devices filed under CLINICAL USE TRAYS AND BOWLS.