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Pulse Oximeter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref YM201Model 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
- YM201 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
- 06972911370036 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972911370036 EUDAMED697291137YM4A EUDAMED
- Direct Marketing DI
- 06972911370036 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 — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06972911370036 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06972911370036 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (3)
- EUDAMED 8727dacc-f6fa-40e5-ada5-f2700f790354 61 fields · synced Jul 27, 2026
- EUDAMED 12643cc5-901b-412d-ae9d-5a22b1b37057 61 fields · synced May 19, 2026
- FDA UDI 22f6352b-6499-4b5e-af1a-f5ae9f7adf80 32 fields · synced May 30, 2026