Identity
- Trade Name
- HORIGEN EUDAMEDFDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- Electrical Breast Pump EUDAMED
- Model / Reference
- XN-2212M2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06940657902019 EUDAMEDFDA UDI
- Basic UDI-DI
- 6940657902C5 EUDAMED
- 510(k) Number
- K143585 FDA UDI
- FDA Product Code
- HGX FDA UDI
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
- GMDN Term
- Breast pump, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5160 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Horigen by Guangdong Horigen Mother & Baby Products Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6940657902C5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000021982
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 89ecaebb-9d07-4b3e-bc8e-0e2f71d00a15 61 fields · synced Oct 6, 2026
- FDA UDI 97274c63-d146-444b-ab93-2db892c94342 33 fields · synced May 30, 2026