Identity
- Trade Name
- LOREMED EUDAMED
- Device Name
- 3 piece Disposable Valve Set for Pentax Endoscope (Sterile) (Air-water/Suction/Biopsy valve) EUDAMED
- Model / Reference
- VS11PE3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682952418069 EUDAMED
- Basic UDI-DI
- B-08682952418069 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastro-urological guidewire, single-use
Loremed by Pergo Medikal ve Ilac Sanayi A.S. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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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-08682952418069 | Class I | Active |
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Manufacturer
- Manufacturer
- Pergo Medikal ve Ilac Sanayi A.S.
- EUDAMED SRN
- TR-MF-000020761
Sources (1)
- EUDAMED 41db2083-0bce-42c1-a9cd-bd91603c7fe9 61 fields · synced Jun 18, 2026