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Disposable Blood Lancets
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 01-0133DRef Soft 28GRef 01-0123Ref 01-0128Ref 354227Ref 01-0130Ref 01-0128 Soft 28GRef 01-0130 Soft 30GRef Soft 30G
Identity
- Trade Name
- Sterilance Disposable Blood Lancets EUDAMED
- Device Name
- Disposable Blood Lancets EUDAMED
- Model / Reference
- 01-0133D EUDAMEDSoft 28G EUDAMED01-0123 EUDAMED01-0128 EUDAMED354227 EUDAMED01-0130 EUDAMED01-0128 Soft 28G EUDAMED01-0130 Soft 30G EUDAMEDSoft 30G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630123655 EUDAMED16945630141239 EUDAMED16945630123631 EUDAMED16945630123747 EUDAMED16945630122818 EUDAMED16945630123723 EUDAMED06945630115752 EUDAMED16945630123624 EUDAMED16945630120890 EUDAMED16945630115742 EUDAMED16945630123532 EUDAMED16945630130820 EUDAMED16945630122825 EUDAMED16945630116619 EUDAMED16945630142915 EUDAMED16945630118385 EUDAMED16945630142885 EUDAMED16945630125369 EUDAMED16945630116626 EUDAMED16945630120883 EUDAMED06945630116124 EUDAMED16945630123570 EUDAMED16945630125536 EUDAMED16945630116633 EUDAMED
- Basic UDI-DI
- 6945630101DUX EUDAMED6945630101B9 EUDAMED
- Unit of Use DI
- 06945630123658 EUDAMED06945630141232 EUDAMED06945630123634 EUDAMED06945630123740 EUDAMED06945630122811 EUDAMED06945630123726 EUDAMED06945630123627 EUDAMED06945630120893 EUDAMED06945630115745 EUDAMED06945630123535 EUDAMED06945630130823 EUDAMED06945630122828 EUDAMED06945630116612 EUDAMED06945630142918 EUDAMED06945630118388 EUDAMED06945630142888 EUDAMED06945630125362 EUDAMED06945630120886 EUDAMED06945630123573 EUDAMED06945630125539 EUDAMED06945630116636 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDGermany EUDAMEDBelgium EUDAMEDNorthern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Disposable Blood Lancets by Sterilance Medical (Suzhou) Inc. — Class IIa — 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 | K221507 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6945630101DUX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (25)
- EUDAMED 321740fe-4c60-495e-8c05-1ff16f7164ff 61 fields · synced Aug 3, 2026
- EUDAMED bf922537-a9ac-4efc-9542-2176adf38f2a 61 fields · synced May 11, 2026
- EUDAMED 0480e8c8-d692-43f6-b65d-a4928e23e063 61 fields · synced May 11, 2026
- EUDAMED 4a9819ed-311f-48e2-9d6d-2d0fdfc34778 61 fields · synced May 17, 2026
- EUDAMED ed1e8073-463a-49a3-a8a9-9d27055c1f8b 61 fields · synced May 17, 2026
- EUDAMED 80637416-6523-4c7a-9612-a0018379f667 61 fields · synced May 17, 2026
- EUDAMED 8d0c83ed-431c-4c7a-b4b5-412780f22e36 61 fields · synced May 17, 2026
- EUDAMED 287c66fb-3ce9-432f-a1d3-9e4f753c1436 61 fields · synced May 17, 2026
- EUDAMED 05f34e15-f8fd-4bdc-8dca-2ff5d9d41a05 61 fields · synced May 17, 2026
- EUDAMED 47635dcb-0090-4859-8ee1-1b5e3ae9a9d0 61 fields · synced May 18, 2026
- EUDAMED 6254f978-d6a7-4400-b120-993a842c25cc 61 fields · synced Jun 20, 2026
- EUDAMED 8258669e-3bd2-4d65-9146-be2c3f65347e 61 fields · synced Jul 10, 2026
- EUDAMED fa6b981d-d878-41ef-af20-cd8c08a0aa2f 61 fields · synced Jul 11, 2026
- EUDAMED 2ac99ce3-d732-4871-9204-c458b4cf552f 61 fields · synced Jul 13, 2026
- EUDAMED eab32069-4dcd-40f0-8ce1-c6fccbd134bc 61 fields · synced Jul 18, 2026
- EUDAMED 6cd4201e-64ca-48af-a707-497571d91424 61 fields · synced Jul 19, 2026
- EUDAMED a3486852-83bd-4896-9065-10ee4a7604d6 61 fields · synced Jul 20, 2026
- EUDAMED f5fdbe4c-3b05-4840-9806-dc2bca1ed259 61 fields · synced Jul 21, 2026
- EUDAMED f7abaf30-3ab5-40c9-b032-2d1e158735f3 61 fields · synced Jul 23, 2026
- EUDAMED c002f564-d7e9-4920-81b9-9265085855a1 61 fields · synced Jul 24, 2026
- EUDAMED 46204ed9-993a-4511-82b5-af9ab6c411c5 61 fields · synced Jul 28, 2026
- EUDAMED d3334621-0e7b-444f-aa04-087fa3aa26a8 61 fields · synced Jul 29, 2026
- EUDAMED a4ceac5a-e908-4a74-a4f7-8db192f75d41 61 fields · synced Jul 29, 2026
- EUDAMED 56dabe57-e90e-442f-a4db-89c5ea7188ca 61 fields · synced Aug 3, 2026
- FDA 510(k) K221507 1 fields · synced May 18, 2026