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SPECTRA Silicone valve
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NAModel Spectra S1 Plus
by Uzinmedicare
Identity
- Trade Name
- SPECTRA Silicone valve EUDAMEDSpectra FDA UDI
- Generic Name
- Breast pump support kit, reusable FDA UDI
- Device Name
- Electric breast pump EUDAMEDA collection of non-sterile items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device. FDA UDI
- Model / Reference
- Spectra S1 Plus EUDAMEDNA EUDAMEDSpectra accessory(Silicone head set) FDA UDI
- Description
- A collection of non-sterile items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- MM012388 FDA UDI
- Primary DI / UDI-DI
- 08809108012388 EUDAMEDFDA UDI
- Basic UDI-DI
- 880910801SPSS001UU EUDAMED
- Direct Marketing DI
- 08809108012388 EUDAMED
- FDA Product Code
- HGX FDA UDI
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
- GMDN Term
- Breast pump support kit, reusable 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
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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SPECTRA Silicone valve by Uzinmedicare — 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 | 880910801SPSS001UU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Uzinmedicare
- EUDAMED SRN
- KR-MF-000031282
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b4bd1d0a-3a6b-416b-a3fe-b5cf2a74f2a0 61 fields · synced Jul 9, 2026
- FDA UDI 50793a14-3503-47ec-a560-6a90027ffc82 35 fields · synced May 30, 2026