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Smart Syringe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 41Model SKT-SS-100
by Bsl Co. Ltd.
Identity
- Trade Name
- Smart Syringe EUDAMEDFDA UDI
- Generic Name
- Autologous adipose tissue reinjection set FDA UDI
- Device Name
- SKT-SS-100 EUDAMED
- Model / Reference
- SKT-SS-100 EUDAMEDFDA UDI41 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800080211011 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800080211011 EUDAMED
- FDA Product Code
- QKL FDA UDI
- EMDN Code
- V901601 PLASTIC SURGERY AND NON-AESTHETIC PURPOSES GENERIC USE INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Autologous adipose tissue reinjection set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Smart Syringe by BSL Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800080211011 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED ab56b837-840a-4e6b-993a-2710a71e23e6 61 fields · synced Jul 20, 2026
- FDA UDI 52a0b324-77ec-4142-b425-deeb2d983627 34 fields · synced May 30, 2026