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Being
EUDAMEDClass IIb (EU MDR)
Ref 01.78.127Model BRW-3000ARef 01.78.124Model BBP-3000BRef 01.78.006Model BIN-4000CRef 01.78.130Model BRW-4000BRef 01.78.003Model BIN-3000BRef 01.78.005Model BIN-4000BRef 01.78.120Model BBP-1000B
Identity
- Trade Name
- BEING EUDAMED
- Device Name
- Infant Radiant Warmers EUDAMEDInfant Phototherapy Equipments EUDAMEDInfant Incubator EUDAMED
- Model / Reference
- BRW-3000A EUDAMED01.78.127 EUDAMEDBBP-3000B EUDAMED01.78.124 EUDAMEDBIN-4000C EUDAMED01.78.006 EUDAMEDBRW-4000B EUDAMED01.78.130 EUDAMEDBIN-3000B EUDAMED01.78.003 EUDAMEDBIN-4000B EUDAMED01.78.005 EUDAMEDBBP-1000B EUDAMED01.78.120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974990910059 EUDAMED06974990910110 EUDAMED06974990910042 EUDAMED06974990910080 EUDAMED06974990910011 EUDAMED06974990910035 EUDAMED06974990910097 EUDAMED
- Basic UDI-DI
- B-06974990910059 EUDAMEDB-06974990910110 EUDAMEDB-06974990910042 EUDAMEDB-06974990910080 EUDAMEDB-06974990910011 EUDAMEDB-06974990910035 EUDAMEDB-06974990910097 EUDAMED
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS EUDAMEDZ12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMEDZ1208040302 MOBILE NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Being by Being Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974990910059 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Being Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000041053
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (7)
- EUDAMED ec3530ba-37af-45ff-a0a5-83b19ed095ce 61 fields · synced Jul 30, 2026
- EUDAMED 84bb9d0e-3121-4bb6-bec0-490ebe489c60 61 fields · synced May 16, 2026
- EUDAMED f8aca9ac-62ad-4330-a3f0-c8f38f1afe57 61 fields · synced May 16, 2026
- EUDAMED 651b1a8a-7fab-4dbf-b138-eed7cf947d8e 61 fields · synced May 18, 2026
- EUDAMED 1698d765-6e1b-4900-b19b-5333c5070c67 61 fields · synced May 18, 2026
- EUDAMED 5f11651c-4d6a-487e-ad4b-877fad230b73 61 fields · synced May 18, 2026
- EUDAMED ed836a0f-5a09-4010-b797-c36f678367d5 61 fields · synced Jul 18, 2026