Electric wheelchair
by Xuzhou Heabens Medical Technology Co., LTD. 11 variants
Ref 0120, 0122, 0060, 0011, 0020, 0012, 0030, 0014, 0010, 0080, 0141, 0070, 0191, 0190, 0130, 0026, 0036, 0012A, 0023Model 0010;0011;0012;0012A;0014;0016;0017;0020;0021;0022;0023;0026;0027;0030;0031;0036;0037;0040;0043;0050;0060;0060C;0061;0062;0070;0071;0080;0081;0090;0091;0092;0141;0141R;0190;0191;0120;0121;0122;0130;0130AF;0130AR;0131;0132;0170;0180;0290;0290HB;CF01;CF02
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 | Number697521376EWH01JH | Date26 Jul 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- Withdrawn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
- Electric wheelchair
- Model / Reference
- 0010, 0011, 0012, 0012A, 0014, 0016, 0017, 0020, 0021, 0022, 0023, 0026, 0027, 0030, 0031, 0036, 0037, 0040, 0043, 0050, 0060, 0060C, 0061, 0062, 0070, 0071, 0080, 0081, 0090, 0091, 0092, 0141, 0141R, 0190, 0191, 0120, 0121, 0122, 0130, 0130AF, 0130AR, 0131, 0132, 0170, 0180, 0290, 0290HB, CF01, CF02
- Primary DI / UDI-DI
- 06975213761205, 06975213761229, 06975213760062, 06975213760116, 06975213760024, 06975213760123, 06975213760000, 06975213760147, 06975213760017, 06975213760086, 06975213760796, 06975213760703, 06975213760291, 06975213760192, 06975213760789, 06975213760260, 06975213760284, 06975213760079, 06975213760239
- Basic UDI-DI
- 697521376EWH01JH
- Direct Marketing DI
- 06975213760000
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- ItalyDenmarkTürkiyeGermanyPolandSpainAustriaNorthern IrelandSwedenRomania
Manufacturer details
- EUDAMED SRN
- CN-MF-000031737
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xuzhou Heabens Medical Technology Co., LTD.
See all devices from Xuzhou Heabens Medical Technology Co., LTD. →
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