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Electric Breast Pump
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref LD-302Model LD-202,LD-302Ref LD-202510(k) K241322
Identity
- Trade Name
- Electric Breast Pump EUDAMED
- Device Name
- Electric Breast Pump EUDAMED
- Model / Reference
- LD-202,LD-302 EUDAMEDLD-302 EUDAMEDLD-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392217024 EUDAMED06970392217017 EUDAMED
- Basic UDI-DI
- 6970392211LD0002Y5 EUDAMED
- Direct Marketing DI
- 06970392217024 EUDAMED06970392217017 EUDAMED
- 510(k) Number
- K241322 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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 Joytech Healthcare 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
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 | K172989 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K241322 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211LD0002Y5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 1376b097-a5a6-41b8-b238-97862d06be1b 61 fields · synced Jul 18, 2026
- EUDAMED 92023178-c12e-48ab-85f0-c7ab73011a78 61 fields · synced May 18, 2026
- FDA 510(k) K241322 24 fields · synced May 18, 2026