Identity
- Trade Name
- i-Stitch Rinsing Needle Miele Connector EUDAMED
- Device Name
- i-Stitch Cleaning Instruments EUDAMED
- Model / Reference
- IST1050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EAMIIST10500 EUDAMED
- Basic UDI-DI
- ++EAMIA3B1C1D1H6 EUDAMED
- Direct Marketing DI
- +EAMIIST10500 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT 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
Category: Surgical utensil washer/disinfector
i-Stitch Rinsing Needle Miele Connector by A.m.i. Agency For Medical Innovations Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical utensil washer/disinfector.
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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 | ++EAMIA3B1C1D1H6 | Class I | Active |
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Manufacturer
- Manufacturer
- A.M.I. Agency for Medical Innovations GmbH
- EUDAMED SRN
- AT-MF-000016792
Sources (1)
- EUDAMED 007912d4-156a-49c9-9d2e-4b93b29a8204 61 fields · synced Oct 6, 2026