Identity
- Trade Name
- Reusable Pulse Oximeter Probe EUDAMEDMed-link FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- Reusable Pulse Oximeter Probe EUDAMED
- Model / Reference
- S0136J-L EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944414038027 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444140104SR 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
Yes
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse oximeter probe, single-use
Reusable Pulse Oximeter Probe by Shenzhen Med-link Electronics Tech Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Pulse oximeter probe, single-use.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444140104SR | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (2)
- EUDAMED 0423b980-068c-4bd4-a0e3-c35fb6b84a62 61 fields · synced Jun 19, 2026
- FDA UDI 2a34b3d0-3c71-45dd-832d-3549b96a5af6 33 fields · synced May 30, 2026