HMHT1001L
by MediTouch Ltd Israel EUDAMEDGUDID
Ref DO-15-01-14Model HMHT1001L
Product code IODEMDN Z120602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07290019733003 | Date21 Jun 2023 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number7290019733BF100R7 | Date4 Apr 2023 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- HMHT1001L EUDAMEDHandTutor GUDID
- Generic Name
- Virtual-display rehabilitation system, non-supportive, clinical
- Model / Reference
- HMHT1001L, DO-15-01-14
- Primary DI / UDI-DI
- 07290019733003
- Basic UDI-DI
- 7290019733BF100R7
- 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
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 (22)
- Sterile: No
- Single Use: No
- Implantable: 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 64eac339-170a-4d03-8915-6be9172de7b1
- FDA UDI 7ffaac35-9f7c-4691-a3af-15a14dff6d73