Sleeve
by Shenzhen Lifotronic Technology Co., Ltd. 19 variants
Ref SAP-LG-LModel SAP-RH-M,SAP-RF-M,SAP-AM-M,MAP-RH-M,MAP-RF-M,MAP-AM-M,MAP-AC-M,SAP-SH-M,MAP-RR-M,MAP-BE-L,SAP-LH-M,SAP-LF-M,SAP-LG-M,SAP-LG-S,SAP-LG-L,MAP-LH-M,MAP-LF-M,MAP-LG-M,MAP-LC-M,MAP-SH-M,MAP-RL-M,SAP-SH-XL
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 | Number6970341680112100GL | Date5 Jan 2026 | 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- Withdrawn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
- Model / Reference
- SAP-RH-M,SAP-RF-M,SAP-AM-M,MAP-RH-M,MAP-RF-M,MAP-AM-M,MAP-AC-M,SAP-SH-M,MAP-RR-M,MAP-BE-L,SAP-LH-M,SAP-LF-M,SAP-LG-M,SAP-LG-S,SAP-LG-L,MAP-LH-M,MAP-LF-M,MAP-LG-M,MAP-LC-M,MAP-SH-M,MAP-RL-M,SAP-SH-XL, SAP-LG-L
- Primary DI / UDI-DI
- 16975984061266, 06975984060156
- Basic UDI-DI
- 6970341680112100GL
- Direct Marketing DI
- 1697598406126606975984060156
- EMDN Code
- Z12040285 General medicine therapeutic treatment instruments - consumables
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000005654
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Lifotronic Technology Co., Ltd.
See all devices from Shenzhen Lifotronic 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