HMTS100A
by MediTouch Ltd Israel EUDAMEDGUDID
Ref DO-14-01-03-AModel HM3DT100B
Product code IODEMDN Z120602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07290019733850 | Date21 Jun 2023 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number72900197333D100KX | Date20 Jun 2023 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- HMTS100A EUDAMED3DTutor Station GUDID
- Generic Name
- Virtual-display rehabilitation system, non-supportive, clinical
- Device Name
- 3DTutor
- Model / Reference
- HM3DT100B EUDAMEDDO-14-01-03-A EUDAMEDHMTS100A GUDID
- Primary DI / UDI-DI
- 07290019733850
- Basic UDI-DI
- 72900197333D100KX
- FDA Product Code
- IOD
- EMDN Code
- Z120602 Physiotherapy equipment
- GMDN Term
- Virtual-display rehabilitation system, non-supportive, clinical
- Device Class
- Class I
- Regulation Number
- 890.5350
- Market of Registration
- Poland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | HM3DT100B DO-14-01-03-A | HMTS100A |
Manufacturer details
- EUDAMED SRN
- IL-MF-000025321
- Authorised representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Other devices from Meditouch Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (23)
- Sterile: No
- Single Use: 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
- Lot / Batch Number: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 10f65a03-bc83-496a-b6dd-720566b85c66
- FDA UDI bcca1713-189a-499a-a6b8-99bc5d897966