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Enerpeel Sa-15
EUDAMEDClass IIa (EU MDR)
Ref P-SA-15-20Model ENERPEEL SA-15 20 AMPOLLE
Identity
- Device Name
- ENERPEEL SA-15 EUDAMED
- Model / Reference
- ENERPEEL SA-15 20 AMPOLLE EUDAMEDP-SA-15-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-P-SA-15-20DA EUDAMED
- Basic UDI-DI
- B-P-SA-15-20DA EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Category: Device sterilization/disinfection container, reusable
Enerpeel Sa-15 by General Topics Srl — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-P-SA-15-20DA | Class IIa | Active |
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Manufacturer
- Manufacturer
- General Topics Srl
- EUDAMED SRN
- IT-MF-000031008
Sources (1)
- EUDAMED f77a0e95-d9be-4daa-91ea-a2de971492c5 61 fields · synced Jun 18, 2026