Identity
- Device Name
- CORIS® Smart Seal B EUDAMED
- Model / Reference
- N05524 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09350855000900 EUDAMED
- Basic UDI-DI
- 93508550ERCO-A-SSB-6M EUDAMED
- EMDN Code
- Z12011380 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES 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
CORIS® Smart Seal B by Nanosonics Limited — 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 | 93508550ERCO-A-SSB-6M | Class I | Active |
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Manufacturer
- Manufacturer
- Nanosonics Limited
- EUDAMED SRN
- AU-MF-000014803
- Authorised Representative
- Nanosonics Europe GmbH DE-AR-000005870
Sources (1)
- EUDAMED c3b3da31-749b-443f-9822-8ef35fcd1a76 61 fields · synced Jul 9, 2026