Identity
- Trade Name
- comknife® FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- Microsurgical Scalpel Handles EUDAMEDIs used with disposable microsurgical scalpels forfine sectioning and stripping of blood vessels and soft tissues in surgery ormicrosurgery. FDA UDI
- Model / Reference
- JPD EUDAMEDDB-Z EUDAMEDJPD-DB-Z FDA UDI
- Description
- Is used with disposable microsurgical scalpels forfine sectioning and stripping of blood vessels and soft tissues in surgery ormicrosurgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971503600209 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971503600209 EUDAMED
- FDA Product Code
- GDI FDA UDI
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
- GMDN Term
- Scalpel handle, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Scalpel handle, reusable
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 handle, reusable.
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- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · 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 40519234-d446-4bc5-9cf8-12c6fd2fb3c7 33 fields · synced Jun 19, 2026
- EUDAMED ff50b902-7609-4213-95e7-235a0dbc7846 61 fields · synced Jun 19, 2026