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Stylet (Obturators)
EUDAMEDClass IIa (EU MDR)
Ref 13085Model Stylet (Obturators)
Identity
- Trade Name
- Stylet (Obturators) EUDAMED
- Device Name
- Stylet (Obturators) EUDAMED
- Model / Reference
- Stylet (Obturators) EUDAMED13085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095130858 EUDAMED
- Basic UDI-DI
- 890209513080EB EUDAMED
- EMDN Code
- A070599 CAPS OR OBTURATORS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Stylet (Obturators) by Poly Medicure Limited — 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 | 890209513080EB | Class IIa | 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 ea87bf88-82e7-41c1-ab8e-6a1424433624 61 fields · synced Jun 18, 2026