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luer Caps
EUDAMEDClass I (EU MDR)
Ref 13354Model Luer caps (with injection site)
Identity
- Trade Name
- luer Caps EUDAMED
- Device Name
- Luer Caps EUDAMED
- Model / Reference
- Luer caps (with injection site) EUDAMED13354 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095133545 EUDAMED
- Basic UDI-DI
- 890209513354ER EUDAMED
- EMDN Code
- A07050201 CAPS OR OBTURATORS, PERFORABLE WITH NEEDLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
luer Caps by Poly Medicure Limited — Class I — 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 | 890209513354ER | Class I | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000003380
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED fcb20849-6dc5-4a27-ab2e-4618097b657f 61 fields · synced Jun 18, 2026