aspen surgical®
by Aspen Surgical Products, Inc. 55 variants
Ref 1-519-2222DM
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0840113218000ST5Z 00841912107254 | Date15 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Probe Covers and System Drapes (sterile)
- Model / Reference
- 1-519-2222DM
- Primary DI / UDI-DI
- 00841912107254
- Basic UDI-DI
- 0840113218000ST5Z
- EMDN Code
- T030199 Covers, instruments and equipment - other
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000008255
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Aspen Surgical Products, Inc.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No