Identity
- Trade Name
- MYRO FDA UDI
- Generic Name
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
- Device Name
- Myro EUDAMEDThe MYRO therapy system is generally used for neurological rehabilitation of the upper extremities. FDA UDI
- Model / Reference
- R1 EUDAMED11310 EUDAMED1 FDA UDI
- Description
- The MYRO therapy system is generally used for neurological rehabilitation of the upper extremities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120077180069 EUDAMEDFDA UDI
- Basic UDI-DI
- 912007718MYROE4 EUDAMED
- Direct Marketing DI
- 09120077180069 EUDAMED
- FDA Product Code
- BXB FDA UDI
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Market of Registration
- Austria EUDAMED
- 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
No
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
Yes
FDA UDI
Myro 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 | 912007718MYROE4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tyromotion GmbH
- EUDAMED SRN
- AT-MF-000016168
Sources (2)
- EUDAMED 685f0564-1520-4360-b711-a7b08026f6d9 61 fields · synced Jun 18, 2026
- FDA UDI d8c51e76-ccaa-4025-bcea-89a4d9480025 33 fields · synced May 30, 2026