Manual Wheelchair
by Awatar Medical Aid d.o.o. 4 variants
Ref AW ST X1.00150, AWCF002, AW ST X1.00143, AWSA001, AW BA X1.00522, AW BA X1.00524, AW ST X1.00140, AW ST X1.00148Model Steely 100, Alumi 100,39 cm, black, Barie 100
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number385889357AWSTX1.00150FM | Date30 Aug 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Manual WheelchairWheelchare
- Model / Reference
- Steely 100, AW ST X1.00150, Alumi 100, 39 cm, black, AWCF002, AW ST X1.00143, AWSA001, Barie 100, AW BA X1.00522, AW BA X1.00524, AW ST X1.00140, AW ST X1.00148
- Primary DI / UDI-DI
- 03858893570592, 03858893570721, 03858893570578, 03858893570660, 03858893571360, 03858893571377, 03858893570561, 03858893571582, 03858893570677
- Basic UDI-DI
- 385889357AWSTX1.00150FM, 385889357AWSA0022X, 385889357AWSTX1.00143FQ, 385889357AWBAX1.00522JX, 385889357AWBAX1.00524K3, 385889357AWSTX1.00140FJ, 385889357AWSTX1.00148G2
- Direct Marketing DI
- 038588935705920385889357072103858893570578038588935706600385889357136003858893571377038588935705610385889357158203858893570677
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Croatia
Manufacturer details
- EUDAMED SRN
- HR-MF-000025777
Other devices from Awatar Medical Aid d.o.o.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No