Identity
- Trade Name
- Giraffe Blue Spot PT Lite EUDAMED
- Device Name
- Giraffe Blue Spot PT Lite EUDAMED
- Model / Reference
- M1238496 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278837974 EUDAMED
- Basic UDI-DI
- 8406821BUG00394HW EUDAMED
- Direct Marketing DI
- 00195278837974 EUDAMED
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Giraffe Blue Spot PT Lite by Datex-Ohmeda Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00394HW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000002206
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED f290cf8f-c1ea-4951-94f5-1557443d5606 61 fields · synced Jul 10, 2026