Identity
- Trade Name
- Zippie Iris EUDAMEDFDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- Manual Wheelchair Tilt EUDAMEDThe Zippie IRIS® rotation-in-space wheelchair offers a superior combination of positioning, maneuverability, and increased portability with the XLOCK® folding crossbrace option. FDA UDI
- Model / Reference
- Zippie Iris EUDAMEDIRIS FDA UDI
- Description
- The Zippie IRIS® rotation-in-space wheelchair offers a superior combination of positioning, maneuverability, and increased portability with the XLOCK® folding crossbrace option. FDA UDI
Identifiers
- Catalog Number
- EIZ5A FDA UDI
- Primary DI / UDI-DI
- 00016958048957 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958mwctiltHV EUDAMED
- Direct Marketing DI
- 00016958048957 EUDAMED
- FDA Product Code
- IOR FDA UDI
- EMDN Code
- Y122106 REAR SELF-PROPELLED WHEELCHAIRS EUDAMED
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3850 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Zippie Iris 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 | 0016958mwctiltHV | 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 d2d9e1d6-f4e2-4df4-949e-eb558d7419ab 61 fields · synced Oct 6, 2026
- FDA UDI be283f74-3ae1-4296-8022-0a274dd01b60 34 fields · synced May 30, 2026