Identity
- Trade Name
- EXEL SCALPELS ,S-S, SIZE:15 EUDAMEDFDA UDIEXEL Disposable Scalpel, Stainless Steel Size 12 EUDAMED
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- EXEL SCALPEL EUDAMEDEXEL Disposable Scalpel EUDAMEDEXEL SCALPELS ,S-S, SIZE:15 FDA UDI
- Model / Reference
- 29556 EUDAMEDFDA UDI
- Description
- EXEL SCALPELS ,S-S, SIZE:15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00020221295566 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221295566 EUDAMED20221SCPL2953Z EUDAMED
- 510(k) Number
- K895771 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Netherlands EUDAMEDAustria 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scalpel, single-use
Exel Scalpels , S-S, Size:15 by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
- MANI ENT Knife — MANI, INC. · Class I
- Unique Edge — Unique Technologies, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221295566 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221295566 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 1ffe6959-8d50-45b0-9166-f703e2e6588d 61 fields · synced Jul 20, 2026
- FDA UDI a3b18e11-b6cb-4bff-83ab-1631a897fc9d 34 fields · synced May 30, 2026
- EUDAMED fda9c99e-204e-4280-914d-aa622de25b84 61 fields · synced Jul 16, 2026