Identity
- Trade Name
- Medi-Duct EUDAMED
- Device Name
- Medi-Duct EUDAMED
- Model / Reference
- MT63 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B090MT630 EUDAMED
- Basic UDI-DI
- ++B090MT638L EUDAMED
- EMDN Code
- T0210 NON-SURGICAL DRAPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Medi-Duct by ZIEN Medical Technologies, 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 | ++B090MT638L | Class I | Active |
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Manufacturer
- Manufacturer
- ZIEN Medical Technologies, LLC
- EUDAMED SRN
- US-MF-000004717
- Authorised Representative
- Medical Workshop BV NL-AR-000012616
Sources (1)
- EUDAMED ad3b4536-9eda-4334-ac8b-23a41435989a 61 fields · synced Oct 6, 2026