Identity
- Trade Name
- Patient Helper EUDAMEDFDA UDI
- Generic Name
- Trapeze bar exerciser FDA UDI
- Device Name
- Trapeze EUDAMEDA full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars. FDA UDI
- Model / Reference
- 299-5004 EUDAMED299-0100WG-TRI EUDAMEDFDA UDI
- Description
- A full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars. FDA UDI
Identifiers
- Catalog Number
- 299-0100WG-TRI FDA UDI
- Primary DI / UDI-DI
- 00670482000838 EUDAMEDFDA UDI
- Basic UDI-DI
- 67048200075PS EUDAMED
- FDA Product Code
- FNL FDA UDI
- EMDN Code
- V08068099 MEDICAL BEDS - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Trapeze bar exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5100 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Patient Helper by Umano Medical Inc — 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 | 67048200075PS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Umano Medical Inc.
- EUDAMED SRN
- CA-MF-000015592
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0d20ebea-9e4f-4d87-8cb2-725cbf70aa5a 61 fields · synced Oct 6, 2026
- FDA UDI 5972a7f8-1639-47b4-b33a-e275c757713d 34 fields · synced May 30, 2026