← Back to catalogue
Disposable Pulse Oximeter Probe
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S0026M-LModel S0136K-S
Identity
- Trade Name
- Disposable Pulse Oximeter Probe EUDAMEDMed-link FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- Disposable Pulse Oximeter Probe EUDAMED
- Model / Reference
- S0026M-L EUDAMEDS0136K-S EUDAMEDS0136J-L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944414013611 EUDAMEDFDA UDI06944414032469 EUDAMED
- Basic UDI-DI
- B-06944414013611 EUDAMED69444140105ST EUDAMED
- 510(k) Number
- K113727 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Disposable Pulse Oximeter Probe by Shenzhen Med-link Electronics Tech Co., Ltd. — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-06944414013611 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06944414013611 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Med-link Electronics Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011145
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 25e8c5d5-853a-496a-ab63-8c4633b78014 61 fields · synced Sep 30, 2026
- FDA UDI 5a9edde8-2dff-4477-bed8-991dc66d5137 33 fields · synced May 30, 2026
- EUDAMED 1b698171-ca63-4ff9-a7ee-61e36f8677c4 61 fields · synced Sep 17, 2026