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Spo2 sensors
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4)Model P1619-01
Identity
- Trade Name
- Spo2 sensors EUDAMEDMedke FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Spo2 sensors EUDAMED
- Model / Reference
- P1619-01 EUDAMEDFDA UDI(Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971018115281 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971018115281 EUDAMED
- 510(k) Number
- K152390 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
MR Unsafe FDA UDI
Spo2 sensors by Shenzhen Medke Technology Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971018115281 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Medke Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019638
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ff044d2b-0574-4d9c-a650-2d6fee8f68c0 61 fields · synced Jun 8, 2026
- FDA UDI 764ce429-6dc4-471f-8c09-4113240dac0c 33 fields · synced May 30, 2026