Identity
- Trade Name
- Suture PassOR™ EUDAMED
- Device Name
- Laparoscopic Access Device / Endoscopic Access Device EUDAMED
- Model / Reference
- RSG EUDAMEDRSG-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09349967004364 EUDAMED09349967004395 EUDAMED
- Basic UDI-DI
- 93499670FASCLSRE32864ZR EUDAMED
- EMDN Code
- H0199 SURGICAL SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Suture PassOR™ by The O R Company Pty Ltd — Class IIa — 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 | 93499670FASCLSRE32864ZR | Class IIa | Active |
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Manufacturer
- Manufacturer
- The O R Company Pty Ltd
- EUDAMED SRN
- AU-MF-000010179
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 25835d9b-106e-4035-ae4e-e5aad4dfcf7b 61 fields · synced Jul 14, 2026
- EUDAMED d53d1a62-4865-4b32-a14d-24ccd125dc32 61 fields · synced May 18, 2026