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Vitrex
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 333313 Sterile Heel Incision Safety Lancet 1.0x2.5mmRef 331313 Sterile Heel Incision Safety Lancets 2.0x3.0mmRef 399213 Press2 30G 1.8mmRef 395213 Press2 21G 2.2mmRef 351213 Soft 23GRef Elite 21G 2.4mmRef 335313 Sterile Heel Incision Safety Lancets 0.65x1.4mmRef 396413Ref 331213Ref 354413 Soft 30GRef 393213 Press2 18G 1.8mmRef 398413Ref 394213 Press2 26G 1.8mmRef Elite 17G 2.0mmRef Elite 21G 1.8mmRef 397213 Press2 21G 1.8mmRef 357213 Soft 32GRef 395813 Flex3 23GRef Elite 28G 1.8mmRef 393413Ref 334213Ref 392413Ref 333213Ref 352413 Soft 28GRef 334313 Sterile Heel Incision Safety Lancets 0.85x1.75mmRef 354417Ref 394413
Identity
- Trade Name
- VITREX EUDAMED
- Device Name
- Heel Incision EUDAMEDDisposable Safety Lancets EUDAMEDDisposable Blood Lancets EUDAMED
- Model / Reference
- 333313 Sterile Heel Incision Safety Lancet 1.0x2.5mm EUDAMED331313 Sterile Heel Incision Safety Lancets 2.0x3.0mm EUDAMED399213 Press2 30G 1.8mm EUDAMED395213 Press2 21G 2.2mm EUDAMED351213 Soft 23G EUDAMEDElite 21G 2.4mm EUDAMED335313 Sterile Heel Incision Safety Lancets 0.65x1.4mm EUDAMED396413 EUDAMED331213 EUDAMED354413 Soft 30G EUDAMED393213 Press2 18G 1.8mm EUDAMED398413 EUDAMED394213 Press2 26G 1.8mm EUDAMEDElite 17G 2.0mm EUDAMEDElite 21G 1.8mm EUDAMED397213 Press2 21G 1.8mm EUDAMED357213 Soft 32G EUDAMED395813 Flex3 23G EUDAMEDElite 28G 1.8mm EUDAMED393413 EUDAMED334213 EUDAMED392413 EUDAMED333213 EUDAMED352413 Soft 28G EUDAMED334313 Sterile Heel Incision Safety Lancets 0.85x1.75mm EUDAMED354417 EUDAMED394413 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630117531 EUDAMED16945630117579 EUDAMED16945630119467 EUDAMED16945630119429 EUDAMED16945630119009 EUDAMED16945630138048 EUDAMED16945630117562 EUDAMED16945630119771 EUDAMED16945630119931 EUDAMED16945630118811 EUDAMED16945630119405 EUDAMED16945630119795 EUDAMED16945630119443 EUDAMED16945630138000 EUDAMED16945630138031 EUDAMED16945630119412 EUDAMED16945630118996 EUDAMED16945630118514 EUDAMED16945630138017 EUDAMED16945630119740 EUDAMED16945630119900 EUDAMED16945630125031 EUDAMED16945630119894 EUDAMED16945630118804 EUDAMED16945630117548 EUDAMED16945630135474 EUDAMED16945630119757 EUDAMED
- Basic UDI-DI
- 6945630130BG EUDAMED6945630105BH EUDAMED6945630101B9 EUDAMED6945630105DVB EUDAMED
- Unit of Use DI
- 06945630117534 EUDAMED06945630117572 EUDAMED06945630119460 EUDAMED06945630119422 EUDAMED06945630119002 EUDAMED06945630138041 EUDAMED06945630117565 EUDAMED06945630119774 EUDAMED06945630119934 EUDAMED06945630118814 EUDAMED06945630119408 EUDAMED06945630119798 EUDAMED06945630119446 EUDAMED06945630138003 EUDAMED06945630138034 EUDAMED06945630119415 EUDAMED06945630118999 EUDAMED06945630118517 EUDAMED06945630138010 EUDAMED06945630119743 EUDAMED06945630119903 EUDAMED06945630125034 EUDAMED06945630119897 EUDAMED06945630118807 EUDAMED06945630117541 EUDAMED06945630135477 EUDAMED06945630119750 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMEDItaly EUDAMEDAustria 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
Vitrex by Sterilance Medical (Suzhou) Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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 | K210745 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6945630130BG | 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 (28)
- EUDAMED 901a9149-5d56-4fc7-b6c4-99b5d3bcd656 61 fields · synced Sep 17, 2026
- EUDAMED 547d99cb-4caa-4053-913b-0139f174eaf4 61 fields · synced May 16, 2026
- EUDAMED 5eb07ae7-3ffb-488c-9cc9-d7c414c3e143 61 fields · synced May 16, 2026
- EUDAMED 1fdf41e6-ebb6-4bc8-add8-b1e18bec2018 61 fields · synced May 16, 2026
- EUDAMED c2ecdbac-8ae2-431c-9add-c97cf8d6dbac 61 fields · synced May 16, 2026
- EUDAMED fd5c95e8-8a96-4f50-8114-240b3fda279d 61 fields · synced May 16, 2026
- EUDAMED 1cdde0a9-2c12-4ee1-af86-1b03a7c97702 61 fields · synced May 16, 2026
- EUDAMED 4e87d2bc-0a35-44a5-a428-b37f68a23d9f 61 fields · synced May 17, 2026
- EUDAMED dd64bb11-85b6-4e9d-a6f4-f3eab8b3de0c 61 fields · synced May 17, 2026
- EUDAMED aceaf738-2bbe-478b-8a6b-5fa3038642dd 61 fields · synced May 17, 2026
- EUDAMED 900a2b01-669f-4a63-9509-fb59029ac432 61 fields · synced May 17, 2026
- EUDAMED 22cd6957-15d0-4047-b23c-69747918ff5d 61 fields · synced May 17, 2026
- EUDAMED 33fda3f5-470b-4ba7-b7cc-fb86c98a7b18 61 fields · synced May 17, 2026
- EUDAMED 2dfebeb4-0bc4-4572-80c7-eb00fce05996 61 fields · synced May 17, 2026
- EUDAMED ce536dda-1429-46c4-b016-90a1e4fbc3db 61 fields · synced May 17, 2026
- EUDAMED 6bfba194-25d3-4c61-b239-bf0ff5262c8b 61 fields · synced May 18, 2026
- EUDAMED 68c6f42a-80d3-4dfb-b561-9c2dd3513c21 61 fields · synced May 18, 2026
- EUDAMED 71a3e62c-f956-4f58-8825-49654d09a18a 61 fields · synced May 18, 2026
- EUDAMED f7cfd4ed-6535-462c-bd29-7d524da7bd25 61 fields · synced May 18, 2026
- EUDAMED f2f295ae-c0f7-4a0e-86f1-588f15f15ef0 61 fields · synced May 18, 2026
- EUDAMED e914f82b-909c-4724-8eed-54c4e75e4c47 61 fields · synced May 18, 2026
- EUDAMED fa0069f1-4750-4fb6-9490-14420069f164 61 fields · synced May 18, 2026
- EUDAMED d63bd5d1-41c6-4877-9f4a-850b46ea5804 61 fields · synced May 18, 2026
- EUDAMED 5f181790-7508-4e87-b4ed-c73001adc9eb 61 fields · synced May 18, 2026
- EUDAMED a6f55aa2-758f-4529-ae81-43d121cf2f74 61 fields · synced May 19, 2026
- EUDAMED 5ed45679-353b-4d10-bab5-c969ff0e1cb2 61 fields · synced May 19, 2026
- EUDAMED 33f87c69-c6db-4d6b-a48c-f9b0344da7c5 61 fields · synced May 19, 2026
- FDA 510(k) K210745 1 fields · synced May 18, 2026