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C50 Intraoral protective sheaths
EUDAMEDFDA UDIClass I (EU MDR)
Ref 403050Model 700342L
by Sopro
Identity
- Trade Name
- C50 Intraoral protective sheaths EUDAMEDActeon FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- PSPIX2 Bag EUDAMEDC50 Protective Sheaths, Camera Cover Clear Polyethylene FDA UDI
- Model / Reference
- 700342L EUDAMED403050 EUDAMED21061 FDA UDI
- Description
- C50 Protective Sheaths, Camera Cover Clear Polyethylene FDA UDI
Identifiers
- Catalog Number
- 403050 FDA UDI
- Primary DI / UDI-DI
- 03760278266870 EUDAMEDFDA UDI
- Basic UDI-DI
- 801337602782P0001GT EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
C50 Intraoral protective sheaths by Sopro — 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 | 801337602782P0001GT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (2)
- EUDAMED b2618603-b153-481a-a4f8-86b95d45141e 61 fields · synced Jun 17, 2026
- FDA UDI 0522fd8e-9f4d-4617-b47e-412f95e3fa67 34 fields · synced May 30, 2026