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Primedge
EUDAMEDClass IIa (EU MDR)
Ref 0407Ref 0403Ref 0711Model 9、10、10A、11、12、12B、12D、13、14、15、15A、15C、15D、16、18、19、20、21、22、22A、 23、24、25、25A、26、27、34、36Ref 0404Ref 0722Ref 0720Ref 0715
Identity
- Trade Name
- PRIMEDGE EUDAMED
- Device Name
- Sterile Blood Lancets EUDAMEDSurgical Blades EUDAMED
- Model / Reference
- 0407 EUDAMED0403 EUDAMED9、10、10A、11、12、12B、12D、13、14、15、15A、15C、15D、16、18、19、20、21、22、22A、 23、24、25、25A、26、27、34、36 EUDAMED0711 EUDAMED0404 EUDAMED0722 EUDAMED0720 EUDAMED0715 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951933899992 EUDAMED06951933801346 EUDAMED06951933811116 EUDAMED06951933801353 EUDAMED06951933811222 EUDAMED06951933811208 EUDAMED06951933811154 EUDAMED
- Basic UDI-DI
- 69519338BLFW EUDAMED69519338SBGV EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Latvia 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
Primedge by Huaian Tianda Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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- DropSafe Medlance Plus, safety lancets — HTL STREFA S A · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69519338BLFW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Huaian Tianda Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000031504
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (7)
- EUDAMED c05adeee-cbd3-4227-aae7-0623284d7b79 61 fields · synced Jul 29, 2026
- EUDAMED 2498e2dc-32e7-46f8-8d6d-abc2dbec6c4a 61 fields · synced May 17, 2026
- EUDAMED fd7275e6-6ebf-41aa-b644-726b00fc3ee9 61 fields · synced May 18, 2026
- EUDAMED 0ad06bc4-9483-41a5-8e7a-7620b967598b 61 fields · synced May 18, 2026
- EUDAMED f2d831cb-ec16-4737-a41c-4b7b730c658a 61 fields · synced May 18, 2026
- EUDAMED fe99ca5e-d222-49b1-81dd-a70a47c1de2e 61 fields · synced May 18, 2026
- EUDAMED 8c084f49-e92b-446c-aa0c-9582279c82b2 61 fields · synced May 19, 2026