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Pulse Oximeter
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref OxibandRef BP3FModel BP3F, BP3G, HDM3F, HDM3GRef PF-10AWRef PO2BModel PO2, PO4，PO2A，PO2B，PO2S，PO2C，PO2C-A，PO2C-S， PO4S，PO4C，PO4C-SRef VTM01ARef PO1BRef PO5Model PO5, PO5-1, PO5-2, PO5-3 Ref PO2Ref PO1Ref PF-10BWRef PF-10AModel PF-10AW、PF- 10AW1、PF-10A、PF-10A1、PF-10BW、PF- 10BW1、PF-10B、PF-10B1Ref OximaxModel Oxiband、Oxiduck、Oximax、Oxiduckm、Oxiultra、Oxiultra01、Oxiducku、OxiduckpModel PO6、PO6A、 PO1、 PO1BRef PO4
Identity
- Trade Name
- Viatom EUDAMEDWellue Checkme O2 Max FDA UDIPulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMEDBlood Pressure Monitor with ECG EUDAMED
- Model / Reference
- Oxiband EUDAMEDFDA UDIBP3F, BP3G, HDM3F, HDM3G EUDAMEDBP3F EUDAMEDPF-10AW EUDAMEDPO2, PO4，PO2A，PO2B，PO2S，PO2C，PO2C-A，PO2C-S， PO4S，PO4C，PO4C-S EUDAMEDPO2B EUDAMEDFDA UDIVTM01A EUDAMEDPO1B EUDAMEDPO5, PO5-1, PO5-2, PO5-3 EUDAMEDPO5 EUDAMEDPO2 EUDAMEDPO1 EUDAMEDPF-10BW EUDAMEDPF-10AW、PF- 10AW1、PF-10A、PF-10A1、PF-10BW、PF- 10BW1、PF-10B、PF-10B1 EUDAMEDPF-10A EUDAMEDOxiband、Oxiduck、Oximax、Oxiduckm、Oxiultra、Oxiultra01、Oxiducku、Oxiduckp EUDAMEDOximax EUDAMEDPO6、PO6A、 PO1、 PO1B EUDAMEDPO4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440102359 EUDAMED06934440102649 EUDAMED06934440102434 EUDAMED06934440103837 EUDAMED06934440102410 EUDAMED06934440102397 EUDAMED06934440102199 EUDAMED06934440103813 EUDAMED06934440102380 EUDAMED06934440102441 EUDAMED06934440102694 EUDAMED06934440103790 EUDAMED06934440103868 EUDAMED06934440103806 EUDAMED06934440103851 EUDAMED06934440102793 FDA UDI06934440103080 FDA UDI
- Basic UDI-DI
- B-06934440102359 EUDAMED69344401BP3FNL EUDAMEDB-06934440102434 EUDAMED69344401PO2ZG EUDAMEDB-06934440102410 EUDAMEDB-06934440102397 EUDAMED69344401PO5ZN EUDAMEDB-06934440102380 EUDAMEDB-06934440102441 EUDAMED69344401PF-10AW9D EUDAMED69344401Oxiband29 EUDAMED69344401PO6ZQ EUDAMED
- Direct Marketing DI
- 06934440102649 EUDAMED06934440103837 EUDAMED06934440102199 EUDAMED06934440103813 EUDAMED06934440102694 EUDAMED06934440103790 EUDAMED06934440103868 EUDAMED06934440103806 EUDAMED06934440103851 EUDAMED06934440102397 EUDAMED06934440102441 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMEDZ1203020302,Z12050301 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
- Germany 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
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
Yes
FDA UDI
MR Unsafe FDA UDI
Pulse Oximeter by Shenzhen Viatom Technology Co., Ltd. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06934440102359 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242876 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06934440102359 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Viatom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012182
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (20)
- EUDAMED 2c55dea5-ded4-49c2-b411-583a6971635d 61 fields · synced Aug 3, 2026
- EUDAMED 0a6e7731-a1fd-42b2-adc9-2f147abd1335 61 fields · synced May 17, 2026
- EUDAMED 1e6b076c-7271-48ad-ae50-2e4851042f03 61 fields · synced May 17, 2026
- EUDAMED f7e43cdd-b255-4c13-98aa-5b7491b60144 61 fields · synced May 17, 2026
- EUDAMED 30190cbe-f0e9-49d4-9bb8-9ececd75070a 61 fields · synced May 17, 2026
- EUDAMED 2d6bb31b-0f05-4ee2-8c56-6c82b52baa9a 61 fields · synced May 17, 2026
- EUDAMED 7b8a4977-25df-436a-ad83-33808bb4566d 61 fields · synced May 17, 2026
- EUDAMED 1dc23a94-7622-4186-a7fb-4bbee1a5bf63 61 fields · synced May 18, 2026
- EUDAMED 24043b58-e74f-4e79-b477-6a667fdd4056 61 fields · synced May 18, 2026
- EUDAMED 65a8231c-6882-423a-a97f-f4477d6d9ad2 61 fields · synced May 18, 2026
- FDA UDI dc36c3c6-66e0-401b-abd3-17ee9b91d354 33 fields · synced May 30, 2026
- FDA UDI 77074795-3572-48e1-9956-f93df9bb1945 33 fields · synced May 30, 2026
- EUDAMED af2c0ec0-462a-4c4c-89da-51f4e88419a4 61 fields · synced Jul 15, 2026
- EUDAMED 2fa8bb46-636b-434a-9722-c8308ec24d89 61 fields · synced Jul 21, 2026
- EUDAMED fffa8d9e-edaf-429b-9d3f-f53fea0cc3a0 61 fields · synced Jul 21, 2026
- EUDAMED 83d73629-46b1-4758-afb0-3674ded20847 61 fields · synced Jul 22, 2026
- EUDAMED fff5c381-121d-4f5c-a3f7-de88fcd447ea 61 fields · synced Jul 25, 2026
- EUDAMED 6198235e-140c-49a0-b6f2-5206df30c72b 61 fields · synced Jul 27, 2026
- EUDAMED e29771e1-6419-46a8-8353-5038b83f341b 61 fields · synced Aug 1, 2026
- FDA 510(k) K242876 1 fields · synced May 18, 2026