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Fingertip Pulse Oximeter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref YK-82CRef YK-80BRef YK-84BRef YK-83BRef YK-83ARef YK-81BRef YK-83CRef YK-84CRef YK-84ARef YK-82ARef YK-81ARef YK-80CRef YK-82B
Identity
- Trade Name
- Fingertip Pulse Oximeter EUDAMED
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- YK-82C EUDAMEDYK-80B EUDAMEDYK-84B EUDAMEDYK-83B EUDAMEDYK-83A EUDAMEDYK-81B EUDAMEDYK-83C EUDAMEDYK-84C EUDAMEDYK-84A EUDAMEDYK-82A EUDAMEDYK-81A EUDAMEDYK-80C EUDAMEDYK-82B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921745201092 EUDAMED06921745201023 EUDAMED06921745200088 EUDAMED06921745201146 EUDAMED06921745200101 EUDAMED06921745201115 EUDAMED06921745201108 EUDAMED06921745200040 EUDAMED06921745200118 EUDAMED06921745201153 EUDAMED06921745201139 EUDAMED06921745201078 EUDAMED06921745201047 EUDAMED06921745201030 EUDAMED06921745201122 EUDAMED06921745200071 EUDAMED
- Basic UDI-DI
- B-06921745201092 EUDAMEDB-06921745201023 EUDAMED69217452FPO2V EUDAMEDB-06921745201146 EUDAMEDB-06921745201115 EUDAMEDB-06921745201108 EUDAMEDB-06921745201153 EUDAMEDB-06921745201139 EUDAMEDB-06921745201078 EUDAMEDB-06921745201047 EUDAMEDB-06921745201030 EUDAMEDB-06921745201122 EUDAMED
- Direct Marketing DI
- 06921745200088 EUDAMED06921745200101 EUDAMED06921745200040 EUDAMED06921745200118 EUDAMED06921745200071 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Fingertip Pulse Oximeter by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161938 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06921745201092 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06921745201092 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018890
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (17)
- EUDAMED e5c56428-8969-40db-ad8a-288b82de68d3 61 fields · synced Oct 5, 2026
- EUDAMED edc3dbe7-a868-4698-b97c-cf09dbdfd3fd 61 fields · synced May 11, 2026
- EUDAMED d4d60633-fe76-442e-8a17-c62e23583039 61 fields · synced May 16, 2026
- EUDAMED 5e4336f7-2669-4ca8-8f8c-af699c720ccf 61 fields · synced May 16, 2026
- EUDAMED d1e66177-e0b8-4cb8-9bbb-6d981e382c87 61 fields · synced May 17, 2026
- EUDAMED 70dddb4b-48b8-4b6d-8189-acee2f83ec16 61 fields · synced May 17, 2026
- EUDAMED 12b48f61-cb98-444f-b2fa-6d9b89a4fc66 61 fields · synced May 17, 2026
- EUDAMED 4585dba9-137d-47e7-a784-512d898071f5 61 fields · synced May 17, 2026
- EUDAMED fc0e020d-2924-4f39-93ca-4f16f817ea7a 61 fields · synced May 18, 2026
- EUDAMED ca23c244-41aa-425f-a5ac-a2f9c4625253 61 fields · synced May 19, 2026
- EUDAMED d57b96d0-2590-4eb9-9f19-ead36a17410c 61 fields · synced May 19, 2026
- EUDAMED f8abb759-8992-4192-8a39-81bca0d435ce 61 fields · synced May 19, 2026
- EUDAMED 1bd8a892-eaf8-473b-9983-a1cad5591618 61 fields · synced May 19, 2026
- EUDAMED 4e48688d-37a5-4e82-a361-5020f7da1bd0 61 fields · synced May 19, 2026
- EUDAMED ccce2bdd-57b8-4b28-a4f6-29557a03624c 61 fields · synced May 19, 2026
- EUDAMED bee65a83-8044-4eef-b2b7-6b59b90cc19c 61 fields · synced May 19, 2026
- FDA 510(k) K161938 1 fields · synced May 18, 2026