Edge-Ease Cushions
by Crosstex International Inc EUDAMEDGUDID 2 variants
Active
Ref BWEEWModel Dental X-Ray Comfort Cushions
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0732224ImagingComfortPU | Date28 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10732224002979 | Date29 Sep 2022 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Generic Name
- Dental x-ray film holder, single-use
- Model / Reference
- Dental X-Ray Comfort Cushions, BWEEW
- Primary DI / UDI-DI
- 10732224002979
- Basic UDI-DI
- 0732224ImagingComfortPU
- Unit of Use DI
- 00732224002972
- 510(k) Number
- FDA Product Code
- EGZ
- EMDN Code
- Z1103040102 Equipment for digital endoral radiology
- GMDN Term
- Dental x-ray film holder, single-use
- Device Class
- Class I
- Regulation Number
- 872.1905
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000009642
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Crosstex International, Inc.
Properties
Other properties (22)
- Sterile: No
- 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
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No