Identity
- Trade Name
- Wallaby EUDAMED
- Device Name
- Infant Incubator with Accessories EUDAMEDInfant Incubator EUDAMED
- Model / Reference
- nice 3010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989112 EUDAMED
- Basic UDI-DI
- 08908003989WallabyY5 EUDAMEDB-08908003989112 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
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wallaby by nice Neotech Medical Systems Pvt. Ltd., — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 08908003989WallabyY5 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 08908003989WallabyY5 | 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 (2)
- EUDAMED e1f56029-7b35-44c0-8b80-3fb8ba845489 61 fields · synced Jun 19, 2026
- EUDAMED 7dee69a0-7355-4b63-83b6-2dac2ee605e8 61 fields · synced May 19, 2026