Cybow P
FDA UDIEUDAMEDClass I (US FDA UDI)
by Dfi Co., Ltd
Identity
- Trade Name
- CYBOW P EUDAMEDFDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- CYBOW Series EUDAMEDThe one device that has DI number included 50strips FDA UDIThe one device that has DI number included 100 strips FDA UDI
- Model / Reference
- 0144 EUDAMEDFDA UDICYBOW Series EUDAMED0143 FDA UDI
- Description
- The one device that has DI number included 50strips FDA UDIThe one device that has DI number included 100 strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806141304647 EUDAMED08806141302087 FDA UDI08806141302094 FDA UDI
- Basic UDI-DI
- 88061413US31D0JC EUDAMED
- FDA Product Code
- JIR FDA UDI
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1645 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Cybow P by Dfi Co., Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class II
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- URiSCAN 1 Glucose strip — Yd Diagnostics · Class II
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- TECO DIAGNOSTICS — TECO DIAGNOSTICS · Class I
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Moore Medical — Moore Medical Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | 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
- Dfi Co., Ltd
Sources (3)
- FDA UDI 64832c71-02d7-49ed-8024-0eedd6a8b01d 34 fields · synced Jul 10, 2026
- FDA UDI 46bcebdf-8042-4a19-b07f-e59f357c1084 34 fields · synced May 30, 2026
- EUDAMED fcaea9f0-1748-48d7-8af8-241d3052f9ec 61 fields · synced Jul 10, 2026