Identity
- Trade Name
- ARYS ME EUDAMEDFDA UDI
- Generic Name
- Biomechanical function analysis/rehabilitation software FDA UDI
- Device Name
- Arys Me EUDAMEDARYS me is intended for over-the-counter use for self-directed management of arm rehabilitation without specific treatment or treatment recommendations. FDA UDI
- Model / Reference
- 3 EUDAMEDFDA UDImany EUDAMED
- Description
- ARYS me is intended for over-the-counter use for self-directed management of arm rehabilitation without specific treatment or treatment recommendations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120077180113 EUDAMEDFDA UDI
- Basic UDI-DI
- 912007718ARYSmeH7 EUDAMED
- Direct Marketing DI
- 09120077180113 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Biomechanical function analysis/rehabilitation software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Arys Me by tyromotion GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 912007718ARYSmeH7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tyromotion GmbH
- EUDAMED SRN
- AT-MF-000016168
Sources (2)
- EUDAMED 7f4269b6-c1b4-448d-8e0c-c21ce68c87a3 61 fields · synced Jul 9, 2026
- FDA UDI c353f093-f9f7-46ee-8133-d62c7a6cbe34 33 fields · synced May 30, 2026