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Lancet
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref XLB2618Model XLII, XL-B, XL-C, XL-D, XL-ERef XLB2328Ref XLD2122Ref XLB2318Ref XLB3028Ref XLB2316Ref XLD2828Ref XLD3016Ref XLE2616Ref XLB2320Ref XLE2318Ref XLII2124Ref XLD2618Ref XLD2322Ref XLII2322Ref XLII2120Ref XLE2116Ref XLE2618Ref XLB2322Ref XLD2616Ref XLD3020Ref XLD2816Ref XLD2622Ref XLE2128Ref XLB2128Ref XLB2628Ref XLE2322Ref XLE3028Ref XLE3016Ref XLE2828Ref XLE2316Ref XLB2620Ref XLD2620Ref XLB2828Ref XLE2628Ref XLD3022Ref XLE2622
Identity
- Trade Name
- Lancet EUDAMED
- Device Name
- Lancet EUDAMED
- Model / Reference
- XLII, XL-B, XL-C, XL-D, XL-E EUDAMEDXLB2618 EUDAMEDXLB2328 EUDAMEDXLD2122 EUDAMEDXLB2318 EUDAMEDXLB3028 EUDAMEDXLB2316 EUDAMEDXLD2828 EUDAMEDXLD3016 EUDAMEDXLE2616 EUDAMEDXLB2320 EUDAMEDXLE2318 EUDAMEDXLII2124 EUDAMEDXLD2618 EUDAMEDXLD2322 EUDAMEDXLII2322 EUDAMEDXLII2120 EUDAMEDXLE2116 EUDAMEDXLE2618 EUDAMEDXLB2322 EUDAMEDXLD2616 EUDAMEDXLD3020 EUDAMEDXLD2816 EUDAMEDXLD2622 EUDAMEDXLE2128 EUDAMEDXLB2128 EUDAMEDXLB2628 EUDAMEDXLE2322 EUDAMEDXLE3028 EUDAMEDXLE3016 EUDAMEDXLE2828 EUDAMEDXLE2316 EUDAMEDXLB2620 EUDAMEDXLD2620 EUDAMEDXLB2828 EUDAMEDXLE2628 EUDAMEDXLD3022 EUDAMEDXLE2622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383615282 EUDAMED06950383615268 EUDAMED06950383615459 EUDAMED06950383615237 EUDAMED06950383615411 EUDAMED06950383615220 EUDAMED06950383615619 EUDAMED06950383615626 EUDAMED06950383615770 EUDAMED06950383615244 EUDAMED06950383615732 EUDAMED06950383616609 EUDAMED06950383615534 EUDAMED06950383615503 EUDAMED06950383616630 EUDAMED06950383616579 EUDAMED06950383615671 EUDAMED06950383615787 EUDAMED06950383615251 EUDAMED06950383615527 EUDAMED06950383615640 EUDAMED06950383615572 EUDAMED06950383615558 EUDAMED06950383615718 EUDAMED06950383615213 EUDAMED06950383615312 EUDAMED06950383615756 EUDAMED06950383615916 EUDAMED06950383615879 EUDAMED06950383615862 EUDAMED06950383615725 EUDAMED06950383615299 EUDAMED06950383615541 EUDAMED06950383615367 EUDAMED06950383615817 EUDAMED06950383615657 EUDAMED06950383615800 EUDAMED
- Basic UDI-DI
- 69503836XL0201CANM EUDAMED
- Unit of Use DI
- 86950383615288 EUDAMED86950383615264 EUDAMED86950383615455 EUDAMED86950383615233 EUDAMED86950383615417 EUDAMED86950383615226 EUDAMED86950383615615 EUDAMED86950383615622 EUDAMED86950383615776 EUDAMED86950383615240 EUDAMED86950383615738 EUDAMED06950383616593 EUDAMED86950383615530 EUDAMED86950383615509 EUDAMED06950383616623 EUDAMED06950383616562 EUDAMED86950383615677 EUDAMED86950383615783 EUDAMED86950383615257 EUDAMED86950383615523 EUDAMED86950383615646 EUDAMED86950383615578 EUDAMED86950383615554 EUDAMED86950383615714 EUDAMED86950383615219 EUDAMED86950383615318 EUDAMED86950383615752 EUDAMED86950383615912 EUDAMED86950383615875 EUDAMED86950383615868 EUDAMED86950383615721 EUDAMED86950383615295 EUDAMED86950383615547 EUDAMED86950383615363 EUDAMED86950383615813 EUDAMED86950383615653 EUDAMED86950383615806 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
Category: Blood lancet, single-use
Lancet by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K221839 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69503836XL0201CANM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hebei Xinle Sci&Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000016692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (38)
- EUDAMED dd22627d-c57a-45e6-96cc-6c51abe36c71 61 fields · synced Sep 18, 2026
- EUDAMED c3c9b868-b5f4-4b46-81d5-b88ee2031b33 61 fields · synced May 16, 2026
- EUDAMED 43eed652-4fd7-4552-90c9-882d85692d2e 61 fields · synced May 16, 2026
- EUDAMED 3c9a6fa3-822b-43a4-ae29-8b4fea76126a 61 fields · synced May 16, 2026
- EUDAMED 227f510e-9f17-41a4-bcf1-dd605db7fb24 61 fields · synced May 16, 2026
- EUDAMED e226e4ed-f502-4d72-803d-a25491023c20 61 fields · synced May 16, 2026
- EUDAMED 8d5fdba9-ddf6-442a-bcb5-ba53b086773f 61 fields · synced May 16, 2026
- EUDAMED 31702004-bdfb-4850-bcb7-fad726d8c755 61 fields · synced May 16, 2026
- EUDAMED a05c3377-2084-4d07-87be-48a2f335813a 61 fields · synced May 16, 2026
- EUDAMED 62c5d050-4db8-45e5-8574-9ed6528a7c81 61 fields · synced May 17, 2026
- EUDAMED abdfb4b7-bfa2-465c-9ba3-0cfde4373ff8 61 fields · synced May 17, 2026
- EUDAMED 51c82d1d-9c09-46bd-b2a2-69b84d498892 61 fields · synced May 17, 2026
- EUDAMED d4a80741-bd86-42ae-8b35-b76323e475f1 61 fields · synced May 17, 2026
- EUDAMED dbbf2a36-220b-4736-b816-d1c9a27cdc41 61 fields · synced May 17, 2026
- EUDAMED ad229fc5-d32a-4bab-a891-09cfee797411 61 fields · synced May 17, 2026
- EUDAMED 49c9dada-0991-4ab5-9507-e73ae88612ad 61 fields · synced May 17, 2026
- EUDAMED e62ddf50-ac32-4d56-937a-4395f4bfea40 61 fields · synced May 17, 2026
- EUDAMED add54b87-4d7e-4c7b-9045-63d9eb27c6b7 61 fields · synced May 17, 2026
- EUDAMED 7d87a1a1-ae6f-4baf-93a3-9cd6c8c0c46f 61 fields · synced May 17, 2026
- EUDAMED f9d505f7-fc2b-4211-93b8-7d3da98185fb 61 fields · synced May 18, 2026
- EUDAMED ee6be347-589b-495b-b881-aeedcb5f4ded 61 fields · synced May 18, 2026
- EUDAMED ca3f2133-1db4-441f-8db9-39b5d48a00f2 61 fields · synced May 18, 2026
- EUDAMED f0e16fee-6434-47e5-ab57-6891632cfe44 61 fields · synced May 18, 2026
- EUDAMED 60cf7f90-bbf6-42fe-b7bf-3c0da2f45575 61 fields · synced May 18, 2026
- EUDAMED ec81a2ad-6f5a-48b5-8475-1fab1f6e12b3 61 fields · synced May 18, 2026
- EUDAMED 821e6162-30c2-412c-94d1-77964c40ec13 61 fields · synced May 18, 2026
- EUDAMED ead08cf8-4c3e-41d5-b5a2-e59835d0b69d 61 fields · synced May 18, 2026
- EUDAMED 3051fe62-2647-4231-b64e-fda64691312b 61 fields · synced May 18, 2026
- EUDAMED 9d1d97e3-3d61-4ef8-89c3-6a585449d24d 61 fields · synced May 18, 2026
- EUDAMED 322d294d-7e84-4581-81d6-e597fefb8b69 61 fields · synced May 18, 2026
- EUDAMED e008c039-2a67-4353-9288-73b4ebb08b59 61 fields · synced May 18, 2026
- EUDAMED 15279367-bd68-4601-98e7-6eef04ff101e 61 fields · synced May 18, 2026
- EUDAMED c0b707e6-d09c-4bb1-9a30-c27575d06c3c 61 fields · synced May 18, 2026
- EUDAMED 3262ca58-d593-40c3-afca-1260901aa8fd 61 fields · synced May 18, 2026
- EUDAMED 452c78ad-ba58-492c-bfb6-9cc07acd3c14 61 fields · synced May 19, 2026
- EUDAMED 28a1971f-ec7c-4b00-a6c7-53be20db0cec 61 fields · synced May 19, 2026
- EUDAMED e4462d17-ec4b-4285-a02f-5f2a75189e36 61 fields · synced May 19, 2026
- FDA 510(k) K221839 1 fields · synced May 18, 2026