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Gen.2 Silicone Breast Pump - 150ml
EUDAMEDFDA UDIClass I (EU MDR)
Ref MHK006Model Silicone Breast Pump
Identity
- Trade Name
- Gen.2 Silicone Breast Pump - 150ml EUDAMEDFDA UDI
- Generic Name
- Breast pump, manual FDA UDI
- Device Name
- A manual, silicone breast pump that uses natural suction to draw out milk from the breast or collect let-down during breastfeeding FDA UDI
- Model / Reference
- Silicone Breast Pump EUDAMEDMHK006 EUDAMEDFDA UDI
- Description
- A manual, silicone breast pump that uses natural suction to draw out milk from the breast or collect let-down during breastfeeding FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09420060201048 EUDAMEDFDA UDI
- Basic UDI-DI
- 94200602BFP0012J EUDAMED
- FDA Product Code
- HGY FDA UDI
- EMDN Code
- V020301 MANUAL BREAST PUMPERS AND KITS EUDAMED
- GMDN Term
- Breast pump, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.5150 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gen.2 Silicone Breast Pump - 150ml by Think Green Limited — Class I — 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 | 94200602BFP0012J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Think Green Limited
- EUDAMED SRN
- NZ-MF-000037524
- Authorised Representative
- GRZAN GROUP SL ES-AR-000039086
Sources (2)
- EUDAMED 49bee8d8-fd0d-482e-8248-75165d0cb85b 61 fields · synced Jul 21, 2026
- FDA UDI 4a2aeb6d-924e-4536-863c-01f571d0c1b4 34 fields · synced May 30, 2026