Bite Wing-Ease Barrier Sleeves
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Bite Wing-Ease Barrier Sleeves EUDAMEDBite Wing-Ease™ Barrier Sleeves FDA UDI
- Generic Name
- Dental x-ray film holder, single-use FDA UDI
- Device Name
- X-Ray barrier sleeves FDA UDI
- Model / Reference
- Dental X-Ray Comfort Cushions EUDAMEDBWES EUDAMEDFDA UDI
- Description
- X-Ray barrier sleeves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224002993 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224ImagingComfortPU EUDAMED
- Unit of Use DI
- 00732224002996 EUDAMED
- 510(k) Number
- K852170 FDA UDI
- FDA Product Code
- EGZ FDA UDI
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Dental x-ray film holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.1905 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental digital imaging sensor, intraoral
Bite Wing-Ease Barrier Sleeves by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224ImagingComfortPU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4ec6386f-50f3-4d1b-a7d4-00dba0190aa0 61 fields · synced Oct 6, 2026
- FDA UDI bfaf69a7-295a-419d-80d9-e5d1782f56c0 35 fields · synced May 24, 2026