Identity
- Trade Name
- TECHNO CUT EUDAMEDTECHNOCUT FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Device Name
- Surgical Blades, Scalpel (Surgical Blade with Handle), Scalpel with SIP Feature (Surgical Blade with Handle with Safety Feature), Cartridge-BMS (Blade Management System) EUDAMEDTECHNOCUT STAINLESS STEEL STERILE SURGICAL BLADE #15CA INDIVIDUALLY PACKED FDA UDI
- Model / Reference
- 5191 EUDAMED#15CA FDA UDI
- Description
- TECHNOCUT STAINLESS STEEL STERILE SURGICAL BLADE #15CA INDIVIDUALLY PACKED FDA UDI
Identifiers
- Catalog Number
- 05191 FDA UDI
- Primary DI / UDI-DI
- 18904233151913 EUDAMEDFDA UDI
- Basic UDI-DI
- 89042331V01WV EUDAMED
- Direct Marketing DI
- 18904233151913 EUDAMED
- FDA Product Code
- GES FDA UDI
- EMDN Code
- V010302,V0199 EUDAMED
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Malta 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
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Techno Cut by Niraj Industries Pvt. Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 89042331V01WV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Niraj Industries Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000020562
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED b8fb4820-ae38-48b1-97cd-02c871de3b1c 61 fields · synced Jul 28, 2026
- FDA UDI 5240e50c-39b0-4be2-97a7-01982b1b1d25 34 fields · synced May 30, 2026