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Medisafe Solo
EUDAMEDClass IIa (EU MDR)
Ref 9171Model type 520Ref 7502Ref 8900Ref 9172Ref 7144Ref 8899Ref 7108Model Type 520
Identity
- Trade Name
- Medisafe Solo EUDAMED
- Device Name
- safety lancet EUDAMED
- Model / Reference
- type 520 EUDAMED9171 EUDAMED7502 EUDAMED8900 EUDAMED9172 EUDAMED7144 EUDAMED8899 EUDAMED7108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996099801 EUDAMED05907996098507 EUDAMED05903999605292 EUDAMED05907996099818 EUDAMED15901549097259 EUDAMED05903999605322 EUDAMED05907996098491 EUDAMED
- Basic UDI-DI
- B-05907996099801 EUDAMEDB-05907996098507 EUDAMEDB-05903999605292 EUDAMEDB-05907996099818 EUDAMEDB-15901549097259 EUDAMEDB-05903999605322 EUDAMEDB-05907996098491 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia EUDAMEDLatvia EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
Medisafe Solo by Htl Strefa S A — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05907996099801 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (7)
- EUDAMED 7b55c306-da1a-45d3-b0b7-5f7bde62cb8f 61 fields · synced Aug 1, 2026
- EUDAMED c62e3576-00c1-4025-ae98-f9d841263e44 61 fields · synced May 17, 2026
- EUDAMED a065b5ce-ca43-4623-bef0-2d21cb1523ea 61 fields · synced May 17, 2026
- EUDAMED 52327abe-bbd1-4d0d-939a-6b221e71c5c2 61 fields · synced May 17, 2026
- EUDAMED 7764b77d-58b5-4d6c-bba9-73e1ca9cd16c 61 fields · synced May 18, 2026
- EUDAMED 5120aca3-98e5-4281-a393-a93fa988e155 61 fields · synced May 18, 2026
- EUDAMED de6f6915-49f4-4b15-93a0-d3f1c3bdf690 61 fields · synced May 18, 2026