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Lancing device
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref NoModel HH-X-T,HH-XIII-T,HH-XV-T,HH-XVI-T,HH-XVII-T,HH-XVIII-T,HH-XIX,HH-XXI-T,HH-XXII-T,HH-XXIII-T,HH-XXIV-T,HH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XXXI-T,HH-XXXII-T
Identity
- Device Name
- Lancing device EUDAMED
- Model / Reference
- HH-X-T,HH-XIII-T,HH-XV-T,HH-XVI-T,HH-XVII-T,HH-XVIII-T,HH-XIX,HH-XXI-T,HH-XXII-T,HH-XXIII-T,HH-XXIV-T,HH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XXXI-T,HH-XXXII-T EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138609770 EUDAMED06957138609961 EUDAMED06957138615245 EUDAMED06957138616624 EUDAMED06957138616617 EUDAMED06957138610011 EUDAMED06957138606366 EUDAMED06957138610387 EUDAMED06957138616631 EUDAMED06957138610035 EUDAMED06957138609442 EUDAMED06957138609459 EUDAMED06957138609435 EUDAMED
- Basic UDI-DI
- 69571386LD03U5 EUDAMED
- EMDN Code
- W0501010299 CAPILLARY BLOOD COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDGermany EUDAMEDGreece EUDAMEDNorthern Ireland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lancing device by Tianjin Huahong Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, 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 | K253706 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69571386LD03U5 | Class I | Active |
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Manufacturer
- Manufacturer
- Tianjin Huahong Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015849
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (14)
- EUDAMED 9727f8a1-08c0-478e-a349-0a8d21e29b7d 61 fields · synced Jul 30, 2026
- EUDAMED 6b4e94fd-1cc1-4a43-8d97-e00fa0d97b23 61 fields · synced May 16, 2026
- EUDAMED 3897718e-331e-4c35-b8e3-d7910528b658 61 fields · synced May 16, 2026
- EUDAMED e0872672-3b64-4bb7-879a-4b956ffc2d0e 61 fields · synced May 17, 2026
- EUDAMED 7c08daca-a6b5-44a1-b505-5271a6a59959 61 fields · synced May 17, 2026
- EUDAMED 7f806414-5802-483a-b96d-0e706f3e6777 61 fields · synced Jul 9, 2026
- EUDAMED 7137ea7b-f6c3-444d-a26f-76b1d9901f27 61 fields · synced Jul 10, 2026
- EUDAMED 5d9a265e-9d8e-4e48-be21-16e26458e2f2 61 fields · synced Jul 11, 2026
- EUDAMED ae434b39-9e7c-4546-ac5c-8fc20209cfbe 61 fields · synced Jul 16, 2026
- EUDAMED 6fd3f400-f44f-4763-af7a-f6cbb6cb75db 61 fields · synced Jul 18, 2026
- EUDAMED 852cbf0c-79f3-4f9a-b3d8-2bc73d27cc42 61 fields · synced Jul 21, 2026
- EUDAMED 962b9053-4609-4f81-b5a3-351db14ac8f5 61 fields · synced Jul 26, 2026
- EUDAMED a396d821-4a15-4257-ba15-c00366727cc7 61 fields · synced Jul 27, 2026
- FDA 510(k) K253706 1 fields · synced May 18, 2026