Identity
- Trade Name
- Bebe Donut EUDAMED
- Device Name
- Positioning Device EUDAMED
- Model / Reference
- 10BVE-BD EUDAMED10BB-BD EUDAMED10B-BD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815090013447 EUDAMED00815090013478 EUDAMED00815090013430 EUDAMED
- Basic UDI-DI
- 081509001POSITIONING5X EUDAMED
- EMDN Code
- V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Assistive crawler/mobility board
Bebe Donut by Small Beginnings, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 081509001POSITIONING5X | Class I | Active |
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Manufacturer
- Manufacturer
- Small Beginnings, Inc.
- EUDAMED SRN
- US-MF-000021428
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 07cb3817-887f-4d62-97ea-0d2de2f1189b 61 fields · synced Jul 26, 2026
- EUDAMED 4a6a5038-6e70-42ab-a79d-fb2764ba6ba4 61 fields · synced May 17, 2026
- EUDAMED c3398793-4716-4327-b33f-979a72e25f9b 61 fields · synced May 18, 2026