Identity
- Trade Name
- Zippie Voyage EUDAMEDFDA UDI
- Generic Name
- Stand-up chair, mechanical FDA UDI
- Device Name
- Manual Wheelchair Buggy EUDAMEDThe Zippie Voyage® is a lightweight highly adjustable early intervention stroller. In addition to adjustable tilt and recline, the Voyage also features adjustable head supports, upper body supports and positioning straps. Comes with or without seating. FDA UDI
- Model / Reference
- Voyage EUDAMEDVoyage; Voyage VIP FDA UDI
- Description
- The Zippie Voyage® is a lightweight highly adjustable early intervention stroller. In addition to adjustable tilt and recline, the Voyage also features adjustable head supports, upper body supports and positioning straps. Comes with or without seating. FDA UDI
Identifiers
- Catalog Number
- EIZ14. EIZ16, EIZ18 FDA UDI
- Primary DI / UDI-DI
- 00016958053647 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958mwcbuggys7E EUDAMED
- Direct Marketing DI
- 00016958053647 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- Stand-up chair, mechanical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Zippie Voyage by Sunrise Medical (US) LLC — 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 | 0016958mwcbuggys7E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
- EUDAMED SRN
- US-MF-000007254
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED 2d50d3bd-48ec-463a-baba-261cc8722596 61 fields · synced Jul 29, 2026
- FDA UDI 94e3e4e5-075c-4b62-9bb1-561738848b17 34 fields · synced May 30, 2026