Identity
- Trade Name
- Wallaby EUDAMED
- Device Name
- Infant Incubator EUDAMED
- Model / Reference
- nice 3010 H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989105 EUDAMED
- Basic UDI-DI
- B-08908003989105 EUDAMED
- EMDN Code
- Z1208040301 FIXED NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Wallaby by nice Neotech Medical Systems Pvt. Ltd., — 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-08908003989105 | Class IIb | Active |
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Manufacturer
- Manufacturer
- nice Neotech Medical Systems Pvt. Ltd.,
- EUDAMED SRN
- IN-MF-000010243
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 80f02cb2-6fd4-4a97-aa3f-48073da4571e 61 fields · synced Jul 16, 2026