Identity
- Trade Name
- Hi bebe plus EUDAMED
- Device Name
- Electric Breast Pump EUDAMED
- Model / Reference
- BT-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012310126 EUDAMED
- Basic UDI-DI
- B-08800012310126 EUDAMED
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Hi bebe plus by Bistos Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160274 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800012310126 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bistos Co., Ltd.
- EUDAMED SRN
- KR-MF-000035951
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 5d9418c4-df8d-420e-bcfa-a666f8717ed3 61 fields · synced Jul 14, 2026
- FDA 510(k) K160274 1 fields · synced May 18, 2026