Identity
- Device Name
- SCANLAN® Ochsner Plaque Remover EUDAMED
- Model / Reference
- 9009-150N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00846159021172 EUDAMED
- Basic UDI-DI
- B-00846159021172 EUDAMED
- EMDN Code
- L031306 HEMOSTATIC FORCEPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
SCANLAN® Ochsner Plaque Remover by Scanlan International Inc — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00846159021172 | Class I | Active |
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Manufacturer
- Manufacturer
- Scanlan International Inc.
- EUDAMED SRN
- US-MF-000010251
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED dfb2079c-f1bd-4b17-a481-02d0804a1bff 61 fields · synced Jun 20, 2026