Identity
- Trade Name
- Orchid EUDAMED
- Device Name
- Infant Transport Incubator EUDAMEDInfant Transport Incubator with Accessories EUDAMED
- Model / Reference
- nice 3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989136 EUDAMED
- Basic UDI-DI
- B-08908003989136 EUDAMED08908003989Orchid77 EUDAMED
- EMDN Code
- Z1208040302 MOBILE 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
Orchid by nice Neotech Medical Systems Pvt. Ltd., — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08908003989136 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08908003989136 | 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 14a589bf-8a1c-4331-9edb-d032927b6b21 61 fields · synced Jul 18, 2026
- EUDAMED 940e787b-57e6-4f71-ad4a-8937ac12761b 61 fields · synced May 19, 2026