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Blood pressure cuff
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref A-XT-01Ref A-XT-03-U101Ref A-XT-04D(1)-U3Ref A-XYJ-05NRef A-XT-12D(3)Ref A-XT-12D(1)Ref A-XYJ-02NRef A-XT-04-U101Ref A-XT-12D(4)Ref A-XT-01W(11)-405Ref A-XT-04D(2)-U3Ref A-XT-06-U101Ref A-XT-06D(13)Ref A-XT-02-U101Ref A-XT-05-U1Ref A-XT-05D(12)Ref A-XT-09D(8)Ref A-XT-08D(10)Ref A-XT-04D(3)-U3Ref A-XYJ-15-1Ref A-XT-13W(10)-405Ref A-XT-03W(5)-4Ref A-XT-13W(10)-4Ref A-XT-04D(5)-U3Ref A-XT-12D(5)
Identity
- Trade Name
- Blood pressure cuff EUDAMEDFDA UDIAPK FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDIBlood pressure cuff, single-use FDA UDI
- Device Name
- Blood pressure cuff EUDAMEDFDA UDI
- Model / Reference
- A-XT-01 EUDAMEDFDA UDIA-XT-03W(5)-4 EUDAMEDFDA UDIA-XT-12D(5) EUDAMEDFDA UDIA-XT-08D(10) EUDAMEDFDA UDIA-XT-12D(4) EUDAMEDFDA UDIA-XT-12D(1) EUDAMEDFDA UDIA-XT-12D(3) EUDAMEDFDA UDIA-XT-05D(12) EUDAMEDFDA UDIA-XT-06D(13) EUDAMEDFDA UDIA-XT-03-U101 EUDAMEDA-XT-04D(1)-U3 EUDAMEDA-XYJ-05N EUDAMEDA-XYJ-02N EUDAMEDA-XT-04-U101 EUDAMEDA-XT-01W(11)-405 EUDAMEDA-XT-04D(2)-U3 EUDAMEDA-XT-06-U101 EUDAMEDA-XT-02-U101 EUDAMEDA-XT-05-U1 EUDAMEDA-XT-09D(8) EUDAMEDA-XT-04D(3)-U3 EUDAMEDA-XYJ-15-1 EUDAMEDA-XT-13W(10)-405 EUDAMEDA-XT-13W(10)-4 EUDAMEDA-XT-04D(5)-U3 EUDAMED
- Description
- Blood pressure cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946725523339 EUDAMEDFDA UDI06946725500330 EUDAMEDFDA UDI06946725527009 EUDAMEDFDA UDI06946725526910 EUDAMEDFDA UDI06946725526996 EUDAMEDFDA UDI06946725526965 EUDAMEDFDA UDI06946725526989 EUDAMEDFDA UDI06946725523612 EUDAMEDFDA UDI06946725523629 EUDAMEDFDA UDI06946725512319 EUDAMED06946725503805 EUDAMED06946725545362 EUDAMED06946725545355 EUDAMED06946725512326 EUDAMED06946725512876 EUDAMED06946725503812 EUDAMED06946725512340 EUDAMED06946725512302 EUDAMED06946725512333 EUDAMED06946725546772 EUDAMED06946725503829 EUDAMED06946725504031 EUDAMED06946725512890 EUDAMED06946725500170 EUDAMED06946725503843 EUDAMED
- Basic UDI-DI
- 69467255A-XT-cuffQZ EUDAMED
- 510(k) Number
- K102825 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDIBlood pressure cuff, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Germany EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Blood pressure cuff by APK Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102825 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69467255A-XT-cuffQZ | Class I | Active |
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Manufacturer
- Manufacturer
- APK Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000011581
- Authorised Representative
- Ruiyi Healthcare GmbH DE-AR-000005962
Sources (35)
- EUDAMED 2acdadba-f9f3-4108-af31-cdbcd87a7d2e 61 fields · synced Aug 4, 2026
- FDA UDI 1e8fad50-06b1-46f5-840f-6e048a616033 34 fields · synced May 27, 2026
- FDA UDI 613b9a73-eda6-4941-872f-3e87d2a10436 33 fields · synced May 29, 2026
- FDA UDI e5d9bd9a-da9b-4887-822e-4fd517a8cb29 33 fields · synced May 30, 2026
- FDA UDI 04464228-92d1-43eb-a31b-c62837cbb8c9 33 fields · synced May 30, 2026
- FDA UDI ba1fd465-d05f-4810-a94b-b7979e72c911 33 fields · synced May 30, 2026
- FDA UDI 57501cdb-6d91-47de-82d3-3cad0acdce77 33 fields · synced May 30, 2026
- FDA UDI 39bbd42d-410a-40d0-9dac-76f1453a4ca3 33 fields · synced May 30, 2026
- FDA UDI 1b3d146d-2ea0-46a8-8050-f3d5740e88d2 33 fields · synced May 30, 2026
- FDA UDI 006a1be7-cb72-41e5-8911-bce145d83c89 33 fields · synced May 30, 2026
- EUDAMED 7f334d77-b767-45c7-913d-3b754c765e58 61 fields · synced Jul 9, 2026
- EUDAMED 11511dbb-8edb-4d51-88ed-94b0fe1548a3 61 fields · synced Jul 9, 2026
- EUDAMED 08c6465d-b672-4a22-918f-6a1b31ad7513 61 fields · synced Jul 10, 2026
- EUDAMED c4f2d623-2b5e-43f7-90e6-c9e6fc2e98ce 61 fields · synced Jul 10, 2026
- EUDAMED 5bce86b3-e7a4-40ca-9b11-e12a724ed70a 61 fields · synced Jul 11, 2026
- EUDAMED 346f39b9-976f-4fd1-b339-8c638e0ed82c 61 fields · synced Jul 12, 2026
- EUDAMED 6f67ff1a-c2dc-46b3-bae7-f77705c86411 61 fields · synced Jul 12, 2026
- EUDAMED 4d797feb-233d-4909-83a1-f1cd9d7508fc 61 fields · synced Jul 12, 2026
- EUDAMED 326f0c8a-c427-4e77-bede-9787fe8375bd 61 fields · synced Jul 13, 2026
- EUDAMED 6569b36f-8cda-4573-8818-756d4bbb4935 61 fields · synced Jul 13, 2026
- EUDAMED 5fa95cc0-f97c-46fb-adc3-a89de0c689c5 61 fields · synced Jul 15, 2026
- EUDAMED c78cbd36-38a9-474e-ad59-063a34961e7e 61 fields · synced Jul 16, 2026
- EUDAMED d99eb3ce-8c40-4f97-9ef1-1a8e221af982 61 fields · synced Jul 18, 2026
- EUDAMED 1d32cace-c742-407b-92bb-ad5e1c0d8cf5 61 fields · synced Jul 19, 2026
- EUDAMED 478b2235-74d5-4f9c-a100-e12bc778b476 61 fields · synced Jul 20, 2026
- EUDAMED de30f87a-c9e9-443a-8516-a42556bb3314 61 fields · synced Jul 20, 2026
- EUDAMED 9576d369-c03a-4f91-8aa4-c02e4718ee33 61 fields · synced Jul 20, 2026
- EUDAMED 3fa9c462-b06c-40ec-9e9e-2207b692aaa7 61 fields · synced Jul 21, 2026
- EUDAMED e545a29f-6a90-4d59-b839-31f06ea98f82 61 fields · synced Jul 23, 2026
- EUDAMED 49c47b4c-afbe-4bb7-bfd5-6496038f25de 61 fields · synced Jul 27, 2026
- EUDAMED 96a8133d-0157-411c-a90c-25b37fdf8acd 61 fields · synced Jul 28, 2026
- EUDAMED 4a7b021a-75a0-4d71-8cf0-bce64d48b95b 61 fields · synced Jul 29, 2026
- EUDAMED 62067bab-46a7-449a-aafe-78dc2a37466d 61 fields · synced Aug 4, 2026
- EUDAMED e9414bc3-e60b-422d-88c0-52c2ca9d9803 61 fields · synced Aug 4, 2026
- FDA 510(k) K102825 1 fields · synced May 18, 2026