Identity
- Trade Name
- SuperDART® ONE PASS™ ECCD Kit EUDAMED
- Device Name
- Disposable Cleaning Brushes for Flexible Endoscopes Reprocessing EUDAMED
- Model / Reference
- 9377-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00666416121762 EUDAMED
- Basic UDI-DI
- 666416DCBWT EUDAMED
- Secondary DI
- M453913772 EUDAMED
- Unit of Use DI
- 00666416121755 EUDAMED
- EMDN Code
- V070102 DIGESTIVE ENDOSCOPY ENDOSCOPES CLEANING BRUSHES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
SuperDART® ONE PASS™ ECCD Kit by Primed Instruments Inc — 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 | 666416DCBWT | Class I | Active |
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Manufacturer
- Manufacturer
- PriMed Instruments Inc.
- EUDAMED SRN
- CA-MF-000002760
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b1905ee0-2ece-49a3-8205-80cdc0918566 61 fields · synced Jun 19, 2026