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Electric Breast Pump
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BRP-302Model BRP-301, BRP-302, BRP-303, BRP-304, BRP-305, BRP-306, BRP-307, BRP-308, BRP-201, BRP-202, BRP-203Ref BRP-306Ref BRP-305Ref BRP-308Ref BRP-301
Identity
- Trade Name
- Electric Breast Pump EUDAMED
- Device Name
- Electric Breast Pump EUDAMED
- Model / Reference
- BRP-301, BRP-302, BRP-303, BRP-304, BRP-305, BRP-306, BRP-307, BRP-308, BRP-201, BRP-202, BRP-203 EUDAMEDBRP-302 EUDAMEDBRP-306 EUDAMEDBRP-305 EUDAMEDBRP-308 EUDAMEDBRP-301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976313750021 EUDAMED06976313750236 EUDAMED06976313750229 EUDAMED06976313750663 EUDAMED06976313750014 EUDAMED
- Basic UDI-DI
- 697631375BRPXQJ EUDAMED
- Direct Marketing DI
- 06976313750021 EUDAMED06976313750236 EUDAMED06976313750229 EUDAMED06976313750663 EUDAMED06976313750014 EUDAMED
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
Classification
- Device Class
- Class IIa 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
Electric Breast Pump by AOJ HEALTH Technology Co., Ltd. — Class IIa — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233913 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697631375BRPXQJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- AOJ HEALTH Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000037449
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (6)
- EUDAMED f3e7a1de-791d-4a50-bfe7-3c714e3ee6f2 61 fields · synced Jul 29, 2026
- EUDAMED fcc6c90c-a334-4bb3-9586-b1fa47be177a 61 fields · synced May 17, 2026
- EUDAMED 8164c3ae-4921-40f8-90af-3a58041efc6c 61 fields · synced May 17, 2026
- EUDAMED c0a32177-ac9a-497a-94c1-06a909523386 61 fields · synced May 19, 2026
- EUDAMED cb6cc09f-7fb1-44b4-a0c4-e756f107a308 61 fields · synced May 19, 2026
- FDA 510(k) K233913 1 fields · synced May 18, 2026