Medical Thermal Dry Image Film
by Weifang Hengcai Digital Photo Materials Co., Ltd 8 variants
Model RM-HA1 8x10inch,RM-HA1 10x12inch,RM-HA1 11x14inch,RM-HA1 14x17inch,RM-HL 8x10inch,RM-HL 10x12inch,RM-HL 11x14inch,RM-HL 14x17inch
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697555643HCSM001WK 06975556430028 | Date24 Oct 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Thermal Dry Image Film
- Model / Reference
- RM-HA1 8x10inch, RM-HA1 10x12inch, RM-HA1 11x14inch, RM-HA1 14x17inch, RM-HL 8x10inch, RM-HL 10x12inch, RM-HL 11x14inch, RM-HL 14x17inch
- Primary DI / UDI-DI
- 06975556430028
- Basic UDI-DI
- 697555643HCSM001WK
- EMDN Code
- Z130106 Dry thermal printer x-ray films
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000027698
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- 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