Identity
- Trade Name
- PSPIX2 Bag & Cover EUDAMED
- Device Name
- PSPIX2 Bag EUDAMED
- Model / Reference
- 700342L EUDAMED700546 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278266177 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
PSPIX2 Bag & Cover 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 (1)
- EUDAMED 198e7649-e3bc-4f43-b333-fee83809936f 61 fields · synced Jun 18, 2026