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comknife®
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 10*450/18.8*49Model B10*450/P18.8*49
Identity
- Trade Name
- comknife® FDA UDI
- Generic Name
- Adhesive bandage FDA UDI
- Device Name
- Sterile Pad and Bandage Kits EUDAMEDIs used with external fixator of operating tables, the foam pad is used to separate patient’s foot, ankle, and leg from the foot bracket of external fixators of operating table, the elastic bandage used to fix firmly the patient’s position and foot bracket of external fixators of operating table. FDA UDI
- Model / Reference
- B10*450/P18.8*49 EUDAMEDFDA UDI10*450/18.8*49 EUDAMED
- Description
- Is used with external fixator of operating tables, the foam pad is used to separate patient’s foot, ankle, and leg from the foot bracket of external fixators of operating table, the elastic bandage used to fix firmly the patient’s position and foot bracket of external fixators of operating table. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971503604511 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971503604511 EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
- GMDN Term
- Adhesive bandage FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Market of Registration
- Italy 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: Adhesive bandage
comknife® by Beijing Bohai Kangyuan Medical Devices Co., Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 9225b9fd-4992-45d3-8134-b41b642893bc 33 fields · synced Oct 6, 2026
- EUDAMED 08eed4af-1a69-4664-a22f-36954f6741d4 61 fields · synced Aug 2, 2026