Identity
- Trade Name
- Neo-Oris 100 EUDAMED
- Device Name
- Neo-Oris EUDAMED
- Model / Reference
- Neo-Oris EUDAMEDNO100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973596010439 EUDAMED
- Basic UDI-DI
- 697359601NeoOris58 EUDAMED
- Direct Marketing DI
- 06973596010439 EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS 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
Neo-Oris 100 by Conlett Technology 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 | 697359601NeoOris58 | Class I | Active |
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Manufacturer
- Manufacturer
- Conlett Technology Inc
- EUDAMED SRN
- CN-MF-000002101
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 795323a6-5ef9-4351-8538-3391e5163651 61 fields · synced Jul 20, 2026