Identity
- Trade Name
- SATIS + EUDAMED
- Device Name
- SATIS + EUDAMED
- Model / Reference
- 3600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-3600AJ EUDAMED
- Basic UDI-DI
- B-3600AJ EUDAMED
- EMDN Code
- Z1208040301 FIXED NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Satis + by Mediprema — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-3600AJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mediprema
- EUDAMED SRN
- FR-MF-000011274
Sources (1)
- EUDAMED c599927a-bbd6-402e-8b37-e506646ba605 61 fields · synced Jun 19, 2026