Identity
- Device Name
- SCANLAN® CardioVasive Fine Needle Holder EUDAMED
- Model / Reference
- Q-2591-9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00846159036992 EUDAMED
- Basic UDI-DI
- B-00846159036992 EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, 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
Category: Suturing needle holder, reusable
SCANLAN® CardioVasive Fine Needle Holder by Scanlan International Inc — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Suturing needle holder, reusable.
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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-00846159036992 | 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 e2dc5642-eaa3-4d70-9e1c-1f989c3b7b53 61 fields · synced Sep 17, 2026