Identity
- Trade Name
- SCHRODER - BC 12 - BABY CODE EUDAMED
- Device Name
- BC 11 - BABY CODE EUDAMED
- Model / Reference
- BC 11 EUDAMEDBC 12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8682139009509 EUDAMED
- Basic UDI-DI
- 8682139009BCL3 EUDAMED
- EMDN Code
- Z1208040301 FIXED NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
Schroder - Bc 12 - Baby Code by Proma Medikal Ltd Şti — Class I — 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 | 8682139009BCL3 | Class I | Active |
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Manufacturer
- Manufacturer
- Proma Medikal Ltd Şti
- EUDAMED SRN
- TR-MF-000017590
Sources (1)
- EUDAMED f31e24eb-d7c3-463c-b595-10883553bb0a 61 fields · synced Oct 6, 2026