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Protective Sheaths for SOPIX series
EUDAMEDClass I (EU MDR)
Ref 403026Model 700342LRef 403027
by Sopro
Identity
- Trade Name
- Protective Sheaths for SOPIX series EUDAMED
- Device Name
- PSPIX2 Bag EUDAMED
- Model / Reference
- 700342L EUDAMED403026 EUDAMED403027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278263800 EUDAMED03760278263817 EUDAMED
- Basic UDI-DI
- 801337602782P0001GT EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Protective Sheaths for SOPIX series by Sopro — Class I — 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 | 801337602782P0001GT | Class I | Active |
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Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (2)
- EUDAMED 3d2d26bf-10d5-4b0c-bc74-7eb42d054331 61 fields · synced Jul 20, 2026
- EUDAMED c387e3a4-e513-4da6-9e0d-f3983b8df65d 61 fields · synced May 17, 2026