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Ophthalmology irrigation/aspiration tubing lines
EUDAMEDClass IIa (EU MDR)
Ref W-13-004
by Promepla SAM
Identity
- Device Name
- Ophthalmology irrigation/aspiration tubing lines EUDAMED
- Model / Reference
- W-13-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700512905967 EUDAMED
- Basic UDI-DI
- 037005129OPH-PEXJ EUDAMED
- EMDN Code
- Q020601 PHACOEMULSIFICATION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Ophthalmology irrigation/aspiration tubing lines by Promepla SAM — 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 | 037005129OPH-PEXJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promepla SAM
- EUDAMED SRN
- MC-MF-000015769
- Authorised Representative
- Promepla Group S.à r.l. LU-AR-000013458
Sources (1)
- EUDAMED 8ad42cb6-660f-408c-a99e-8dfc66f2a90c 61 fields · synced Jun 18, 2026