Identity
- Trade Name
- NOVUS FDA UDI
- Generic Name
- Assistive pushchair FDA UDI
- Device Name
- Postural reha-buggy intended for teens with important functional impairments, with little or no control of the head and trunk, with little or no functional capacity, who need a particularly robust structure for transport mainly outdoors. FDA UDI
- Model / Reference
- NOVUS-4 TELAIO NERO, TAPPEZZERIA GRIGIO SCURO FDA UDI
- Description
- Postural reha-buggy intended for teens with important functional impairments, with little or no control of the head and trunk, with little or no functional capacity, who need a particularly robust structure for transport mainly outdoors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715704196 FDA UDI
- FDA Product Code
- INM FDA UDI
- GMDN Term
- Assistive pushchair FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Assistive pushchair
Novus by Ormesa Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HOGGI® — Hoggi GmbH · Class I
- HOGGI® — Hoggi GmbH · Class I
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- Under seat storage basket size 1 — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
- EASyS S2 sleeping bag, winter weight — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormesa Srl
Sources (1)
- FDA UDI 9326e201-9d69-4fb1-ab9e-632a935393de 33 fields · synced Jun 1, 2026