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SpO2 sensor
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SH1Ref SHD-IRef SH6Ref 01.57.471747Ref SH3Ref SH4
Identity
- Trade Name
- SpO2 sensor EUDAMEDFDA UDISpO2 Sensor FDA UDINA FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- SpO2 sensor EUDAMED
- Model / Reference
- SH1 EUDAMEDSHD-I EUDAMEDSH6 EUDAMED01.57.471747 EUDAMEDSH3 EUDAMEDSH4 EUDAMEDSHD-I , Infant, disposable FDA UDISpO2 Finger Sensor, adult, 2.5m, reusable FDA UDIWrap, Neonate,1m,reusable FDA UDISpO Sensor（Single-patient use）- pediatric FDA UDI02.57.225039 FDA UDISpO2 Sensor, Wrap, Neonate, 1m, reusable FDA UDISH6, Ear Clip, Adult/Pediatric, 1m, reusable FDA UDISH4 Adult Silicone Soft-tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413805309 EUDAMEDFDA UDI06944413805415 EUDAMEDFDA UDI06944413805330 EUDAMEDFDA UDI06944413805460 EUDAMEDFDA UDI06944413812055 EUDAMEDFDA UDI06944413805347 EUDAMEDFDA UDI06944413807129 EUDAMEDFDA UDI06944413805361 EUDAMEDFDA UDI06944413837706 EUDAMED
- Basic UDI-DI
- 69444138SSG8 EUDAMED
- 510(k) Number
- K202892 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA 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 UDIFDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDIFDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
SpO2 sensor by Edan Instruments, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 69444138SSG8 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (17)
- EUDAMED e6dc6054-ceca-447f-ad02-64851c3a6638 61 fields · synced Aug 4, 2026
- FDA UDI 6e792618-230d-47ee-895f-47f1ea3f912e 32 fields · synced May 29, 2026
- FDA UDI b80abbba-5204-4ca7-af9b-17dd4cadb41f 32 fields · synced May 29, 2026
- FDA UDI 9c93593e-3ed7-4f4f-a2ce-7a96fcc31411 32 fields · synced May 30, 2026
- FDA UDI 8ceace60-37fe-4605-9320-c881314cd006 32 fields · synced May 30, 2026
- FDA UDI 9f806037-e59a-4983-a217-a3ca96b54c39 33 fields · synced May 30, 2026
- FDA UDI 41a89526-314d-4016-a2a0-ba6d31f24864 32 fields · synced May 30, 2026
- FDA UDI e5602d4c-641e-435f-a3b6-2756b9a98696 32 fields · synced May 30, 2026
- FDA UDI c956fa52-94ef-4f25-b44e-2a8a2ee8d92b 32 fields · synced May 30, 2026
- EUDAMED ca0dea61-052e-4f16-913d-c474a9ae7c5d 61 fields · synced Jun 20, 2026
- EUDAMED 030c4182-8321-4565-a886-d2d3c36fea22 61 fields · synced Jul 11, 2026
- EUDAMED 41967944-0191-4560-b4a8-c6cfcae6763c 61 fields · synced Jul 12, 2026
- EUDAMED f206f3c7-68e5-48a0-bcdf-c1c3cbe7c3fe 61 fields · synced Jul 12, 2026
- EUDAMED 8030e0d1-62a0-4c80-a73d-ca9e873ec9fb 61 fields · synced Jul 12, 2026
- EUDAMED bcda34c4-523f-4a99-bfa9-bbc6dfe2be82 61 fields · synced Jul 14, 2026
- EUDAMED ffd9da90-e2de-4019-a52b-2bcaf44ec175 61 fields · synced Aug 3, 2026
- EUDAMED c2563b21-8fcc-466a-b335-e4f148d70b50 61 fields · synced Aug 4, 2026