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Fingertip Pulse Oximeter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref YM302Model YM101, YM102, YM103, YM104, YM201, YM202, YM301, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM401, YM402, YM403, YM501, YM502, YM503, YM504, YM601, YM602, YM603Ref YM314Ref YM602Ref YM202Ref YM114Ref YM104Ref YM111Ref YM403Ref YM211Ref YM212Ref YM504Ref YM401
Identity
- Trade Name
- Fingertip Pulse Oximeter EUDAMED
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- YM101, YM102, YM103, YM104, YM201, YM202, YM301, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM401, YM402, YM403, YM501, YM502, YM503, YM504, YM601, YM602, YM603 EUDAMEDYM302 EUDAMEDYM314 EUDAMEDYM602 EUDAMEDYM202 EUDAMEDYM114 EUDAMEDYM104 EUDAMEDYM111 EUDAMEDYM403 EUDAMEDYM211 EUDAMEDYM212 EUDAMEDYM504 EUDAMEDYM401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972911370135 EUDAMED06972911370203 EUDAMED06972911370296 EUDAMED06972911370128 EUDAMED06972911370173 EUDAMED06972911370111 EUDAMED06972911370142 EUDAMED06972911370234 EUDAMED06972911370180 EUDAMED06972911370197 EUDAMED06972911370272 EUDAMED06972911370210 EUDAMED
- Basic UDI-DI
- 697291137YM4A EUDAMED
- Direct Marketing DI
- 06972911370135 EUDAMED06972911370203 EUDAMED06972911370296 EUDAMED06972911370128 EUDAMED06972911370173 EUDAMED06972911370111 EUDAMED06972911370142 EUDAMED06972911370234 EUDAMED06972911370180 EUDAMED06972911370197 EUDAMED06972911370272 EUDAMED06972911370210 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fingertip Pulse Oximeter by Shenzhen Yimi Life- Technology Co.ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240092 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697291137YM4A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yimi Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000029928
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (13)
- EUDAMED 8b0c9c1b-7de5-44c2-b1ef-1ceac7f89929 61 fields · synced Jul 31, 2026
- EUDAMED 6471065b-966f-427f-a61b-46954b0d18e2 61 fields · synced May 16, 2026
- EUDAMED ffeae5b5-ee91-4a17-be7d-18e83698a64f 61 fields · synced May 17, 2026
- EUDAMED 5e5420fd-ab5d-49b9-ae68-027c88959df6 61 fields · synced May 17, 2026
- EUDAMED 6f619b27-0349-4a06-8d35-76f7d220e507 61 fields · synced May 17, 2026
- EUDAMED 900019c0-bfef-412f-8f2e-6d2851b6588c 61 fields · synced May 17, 2026
- EUDAMED 737da74f-1f1b-48ed-b978-142a76649dd4 61 fields · synced May 18, 2026
- EUDAMED cdbc8921-7de2-45b4-adef-9286797cb8ac 61 fields · synced May 18, 2026
- EUDAMED 77a38038-e170-416d-9812-3f509fc61d5c 61 fields · synced May 18, 2026
- EUDAMED f9211d56-e608-48a0-86a5-4fba73103b46 61 fields · synced May 18, 2026
- EUDAMED 5190c92f-0557-4a86-9053-a3b829822978 61 fields · synced May 18, 2026
- EUDAMED 16add080-d4e5-4b4a-ab33-b4044680a04a 61 fields · synced May 19, 2026
- FDA 510(k) K240092 1 fields · synced May 18, 2026