Identity
- Trade Name
- HORIGEN EUDAMED
- Device Name
- Electrical Breast Pump EUDAMED
- Model / Reference
- XN-2212M2 EUDAMEDKP053_01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06940657902095 EUDAMED
- Basic UDI-DI
- 6940657902C5 EUDAMED
- Direct Marketing DI
- 06940657902095 EUDAMED
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Horigen by Guangdong Horigen Mother & Baby Products Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6940657902C5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000021982
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 39509eba-1085-4334-bf44-e91ef7d5857b 61 fields · synced Jun 9, 2026