Identity
- Trade Name
- Bellema FDA UDI
- Generic Name
- Breast pump, manual FDA UDI
- Device Name
- manual breast pump FDA UDI
- Model / Reference
- XN-2301SY FDA UDI
- Description
- manual breast pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06940657966653 FDA UDI
- FDA Product Code
- HGY FDA UDI
- GMDN Term
- Breast pump, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
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
MR Safe FDA UDI
Category: Breast pump, manual
Bellema by Guangdong Horigen Mother & Baby Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Horigen Mother & Baby Products Co., Ltd.
Sources (1)
- FDA UDI 482052b7-8b93-41db-90a0-899b4b29722f 33 fields · synced May 30, 2026