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Promul
EUDAMEDClass I (EU MDR)
Ref EI GU2 0008 003Model EI GU2 0008 xxx
by ELESTA SpA
Identity
- Trade Name
- PROMUL EUDAMED
- Device Name
- Elesta Needles Guide Kit EUDAMED
- Model / Reference
- EI GU2 0008 xxx EUDAMEDEI GU2 0008 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052286590258 EUDAMED
- Basic UDI-DI
- 805228659EIGU20008xxx4Y EUDAMED
- Direct Marketing DI
- 08052286590258 EUDAMED
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Promul by Elesta Spa — 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 | 805228659EIGU20008xxx4Y | Class I | Active |
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Manufacturer
- Manufacturer
- ELESTA SpA
- EUDAMED SRN
- IT-MF-000037909
Sources (1)
- EUDAMED 33cdf61f-cff0-4eed-8fd7-651b98eb0f15 61 fields · synced Jul 18, 2026