Identity
- Trade Name
- Flexible Video-Choledochoscope FDA UDI
- Generic Name
- Flexible video choledochoscope, single-use FDA UDI
- Model / Reference
- CHV-110J-U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973786291563 FDA UDI
- 510(k) Number
- K243535 FDA UDI
- FDA Product Code
- FBN FDA UDI
- GMDN Term
- Flexible video choledochoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Flexible video choledochoscope, single-use
Flexible Video-Choledochoscope by Shanghai SeeGen Photoelectric Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Flexible video choledochoscope, single-use.
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- eyeMAX(TM) Single-use Video Pancreaticobiliary Scope — Micro-Tech (Nanjing) Co., Ltd. · Class I
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- eyeMAX(TM) Single-use Video Pancreaticobiliary Scope — Micro-Tech (Nanjing) Co., Ltd. · Class I
- Single-Use Choledochoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
- eyeMAX(TM) Single-use Video Pancreaticobiliary Scope — Micro-Tech (Nanjing) Co., Ltd. · Class I
- eyeMAX(TM) Single-use Video Pancreaticobiliary Scope — Micro-Tech (Nanjing) Co., Ltd. · Class I
- eyeMAX(TM) Single-use Video Pancreaticobiliary Scope — Micro-Tech (Nanjing) Co., Ltd. · Class I
Cleared under the same submission
K243535 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shanghai SeeGen Photoelectric Technology Co., Ltd
Sources (1)
- FDA UDI be8a836a-ffeb-4c30-aeda-8938d8857732 33 fields · synced May 30, 2026