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SPECTRA Wearable
EUDAMEDClass IIa (EU MDR)
Ref NAModel Spectra Wearable
by Uzinmedicare
Identity
- Trade Name
- SPECTRA Wearable EUDAMED
- Device Name
- Electric breast pump EUDAMED
- Model / Reference
- Spectra Wearable EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809108018366 EUDAMED
- Basic UDI-DI
- 880910801SPWR001VZ EUDAMED
- Direct Marketing DI
- 08809108018366 EUDAMED
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
SPECTRA Wearable by Uzinmedicare — 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 | 880910801SPWR001VZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Uzinmedicare
- EUDAMED SRN
- KR-MF-000031282
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9fb0eca0-b9b2-4ce7-ae5e-649283241199 61 fields · synced May 23, 2026