i-Stitch
by A.M.I. Agency for Medical Innovations GmbH United States EUDAMED
Ref IST1010
EMDN A018002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++EAMIA3B9C1D1KW | Date23 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- i-Stitch Instruments
- Model / Reference
- IST1010
- Primary DI / UDI-DI
- +EAMIIST10100
- Basic UDI-DI
- ++EAMIA3B9C1D1KW
- Direct Marketing DI
- +EAMIIST10100
- EMDN Code
- A018002 Needle guides
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- AT-MF-000016792
Other devices from A.M.I. Agency for Medical Innovations GmbH
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: 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
Sources (1)
- EUDAMED +EAMIIST10100|++EAMIA3B9C1D1KW