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Pulse Oximeter
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref YM103Model 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
Identity
- Trade Name
- Pulse Oximeter EUDAMEDFingertip Pulse Oximeter EUDAMEDYIMI LIFE FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMEDFingertip Pulse Oximeter EUDAMED
- Model / Reference
- YM103 EUDAMEDFDA UDIYM101, YM102, YM103, YM104, YM201, YM202, YM301, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM401, YM402, YM403, YM501, YM502, YM503, YM504, YM601, YM602, YM603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972911370029 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972911370029 EUDAMED697291137YM4A EUDAMED
- Direct Marketing DI
- 06972911370029 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pulse Oximeter by Shenzhen Yimi Life- Technology Co.ltd — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191430 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06972911370029 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06972911370029 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yimi Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000029928
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED a5d311e0-4082-4754-bbcd-2df2bf9d9f10 61 fields · synced Jul 16, 2026
- EUDAMED ffdecf3d-4967-41ea-8c3d-7cdfd0242067 61 fields · synced May 16, 2026
- FDA UDI 41fbc79c-68a2-48cf-ba0c-e127f55a2cf9 32 fields · synced May 30, 2026
- FDA 510(k) K191430 1 fields · synced May 18, 2026