Identity
- Trade Name
- comknife® FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- Disposable Microsurgical Scalpels EUDAMEDAre intended for delicate dissection and stripping of blood vessels and soft tissues in surgery or microsurgery FDA UDI
- Model / Reference
- JPD EUDAMEDBL-B-1 EUDAMEDJPD-BL-B-1 FDA UDI
- Description
- Are intended for delicate dissection and stripping of blood vessels and soft tissues in surgery or microsurgery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971503600131 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971503600131 EUDAMED
- FDA Product Code
- GDZ 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 I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Bulgaria 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
No
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
Yes
FDA UDI
Category: Scalpel, single-use
comknife® by Beijing Bohai Kangyuan Medical Devices Co., Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · Class I
- Unique Edge — Unique Technologies, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beijing Bohai Kangyuan Medical Devices Co., Ltd.
Sources (2)
- FDA UDI 098a820e-ae13-4d09-961f-c71ac7b34d95 33 fields · synced Jul 23, 2026
- EUDAMED f1ef7ab6-adb4-446b-87da-72480d7cd633 61 fields · synced Jul 23, 2026