Identity
- Trade Name
- comknife® FDA UDI
- Generic Name
- Leg procedure positioner FDA UDI
- Device Name
- Knee Positioner EUDAMEDMainly used in knee joint surgery to adjust, fix knee flexion and extension, rotation angle and position. FDA UDI
- Model / Reference
- ZJ EUDAMED502mm×263mm EUDAMEDZJ-502mm×263mm FDA UDI
- Description
- Mainly used in knee joint surgery to adjust, fix knee flexion and extension, rotation angle and position. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971503604528 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971503604528 EUDAMED
- FDA Product Code
- ITQ FDA UDI
- EMDN Code
- Y06121203 ACTIVE KNEE-ANKLE-FOOT ORTHOSES EUDAMED
- GMDN Term
- Leg procedure positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 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: Leg procedure positioner
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 Leg procedure positioner.
- Arthrex® — Arthrex, Inc. · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo V2E Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo V2E Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- Proctology support — Reison Medical AB · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
- De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Bohai Kangyuan Medical Devices Co., Ltd.
Sources (2)
- FDA UDI 1f3c4530-07e9-4b52-a649-d65b9640ebf7 33 fields · synced Jul 26, 2026
- EUDAMED 79b08953-e6c5-4320-a337-b3b1bb61924b 61 fields · synced Jul 26, 2026