Identity
- Trade Name
- Smart Syringe EUDAMED
- Device Name
- SKT-SS-100 EUDAMED
- Model / Reference
- SKT-SS-100 EUDAMED42 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800080211028 EUDAMED
- Basic UDI-DI
- B-08800080211028 EUDAMED
- EMDN Code
- V901601 PLASTIC SURGERY AND NON-AESTHETIC PURPOSES GENERIC USE INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Smart Syringe by BSL Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08800080211028 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bsl Co. Ltd.
- EUDAMED SRN
- KR-MF-000025426
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 585a86fc-545f-4799-baae-115984d25679 61 fields · synced Jun 19, 2026