Pulse Oximeter
by Shenzhen Everbest Machinery lndustry Co., Ltd. China EUDAMED
Ref OX-99, OX-97, OX-68, OX-98, OX-99H, OX-68H, OX-97H
EMDN Z1203020408
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69511109OX-99KP | Date9 Jun 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- OX-99, OX-97, OX-68, OX-98, OX-99H, OX-68H, OX-97H
- Primary DI / UDI-DI
- 06951110999132, 06951110997008, 06951110968008, 06951110998074, 06951110999149, 06951110968114, 06951110997077
- Basic UDI-DI
- 69511109OX-99KP, 69511109OX-97KK, 69511109OX-68KC, 69511109OX-98KM, 69511109OX-99HJ2, 69511109OX-68HHG, 69511109OX-97HHU
- Direct Marketing DI
- 06951110999132069511109970080695111096800806951110998074069511109991490695111096811406951110997077
- EMDN Code
- Z1203020408 Pulse oximeters
- Device Class
- Class IIa
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000008730
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (7)
- EUDAMED b009a124-b6bb-4fd9-a140-d0bd51efad31
- EUDAMED 06951110997008|69511109OX-97KK
- EUDAMED 06951110968008|69511109OX-68KC
- EUDAMED 06951110998074|69511109OX-98KM
- EUDAMED 06951110999149|69511109OX-99HJ2
- EUDAMED 06951110968114|69511109OX-68HHG
- EUDAMED 06951110997077|69511109OX-97HHU