Wallaby
by nice Neotech Medical Systems Pvt. Ltd., 2 variants
Ref nice 3010 H
Wallaby (nice 3010 H) is a medical device (EU MDD Class IIb; EMDN category fixed neonatal incubators) made by nice Neotech Medical Systems Pvt. Ltd.,, registered in EUDAMED on 27 Oct 2021 (Basic UDI-DI B-08908003989105), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08908003989105 08908003989105 | Date27 Oct 2021 | StatusActive |
Official records
- EUDAMED public site B-08908003989105
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Infant Incubator
- Model / reference
- nice 3010 H
- Primary DI / UDI-DI
- 08908003989105
- Basic UDI-DI
- B-08908003989105
- EMDN code
- Z1208040301 Fixed neonatal incubators
- Device class
- Class IIb
- System or procedure pack
- System which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- IN-MF-000010243
- Authorised representative
- Amstermed B.V. NL-AR-000001971
Similar devices in this category
Other devices filed under FIXED NEONATAL INCUBATORS.
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- Isolette Infant Incubator, Models C2000 and C2000e MU20500 by Draeger Medical Systems, Inc.
- Dual Incu I by Atom Medical Corporation
- Isolette 8000 Infant Incubator MU20600 by Draeger Medical Systems, Inc.
- Infant incubator BT-500 by Bistos Co., Ltd.
- Infant Incubator YP-3000 by Ningbo David Medical Device Co., Ltd.
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