Identity
- Trade Name
- DONDOLINO 1 - mini EUDAMEDDONDOLINO FDA UDI
- Generic Name
- Manual stander FDA UDI
- Device Name
- DONDOLINO EUDAMEDTilting vertical standing frame indicated for the acquisition and maintenance of an upright position and the training of the antigravity muscles of children who cannot acquire and maintain them independently. Indicated for users suffering from pathologies that determine a deficit of postural control, in which the load of the lower limbs is still allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation and for such as the semi-prone positioning, allows to stimulate the straightening reactions of the trunk and head and to work against gravity. FDA UDI
- Model / Reference
- DONDOLINO EUDAMED50 EUDAMEDDONDOLINO 1 FDA UDI
- Description
- Tilting vertical standing frame indicated for the acquisition and maintenance of an upright position and the training of the antigravity muscles of children who cannot acquire and maintain them independently. Indicated for users suffering from pathologies that determine a deficit of postural control, in which the load of the lower limbs is still allowed, to improve bone density, ventilatory capacity, intestinal peristalsis, bladder function, blood circulation and for such as the semi-prone positioning, allows to stimulate the straightening reactions of the trunk and head and to work against gravity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715705490 EUDAMEDFDA UDI
- Basic UDI-DI
- 805571570DONDOLINOKS EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y050202 STANDING FRAMES EUDAMED
- GMDN Term
- Manual stander FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
DONDOLINO 1 - mini by ORMESA S.r.l. — 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 | 805571570DONDOLINOKS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ORMESA S.r.l.
- EUDAMED SRN
- IT-MF-000034824
Sources (2)
- EUDAMED 516d251e-94b2-4eb3-88ac-ea407178ac41 61 fields · synced Jul 21, 2026
- FDA UDI 6a1a1283-689c-4680-9d56-20dbf13ba028 33 fields · synced May 27, 2026