Clear-Bite Biopsy Forceps
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Clear-Bite Biopsy Forceps EUDAMEDFDA UDI
- Generic Name
- Flexible endoscopic biopsy forceps, single-use FDA UDI
- Device Name
- Single-Use Endoscopic Biopsy Forceps EUDAMEDΦ2.3/ 2,400mm/ Oval FDA UDIΦ2.3/ 2,300mm/ Needle FDA UDI
- Model / Reference
- FM-EF0004 EUDAMEDFDA UDIFM-EFN004 EUDAMEDFDA UDIFM-EFA004 EUDAMED
- Description
- Φ2.3/ 2,400mm/ Oval FDA UDIΦ2.3/ 2,300mm/ Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809327352623 EUDAMEDFDA UDI08809327352647 EUDAMEDFDA UDI08809327352630 EUDAMED
- Basic UDI-DI
- 0880932735EFG5 EUDAMED
- FDA Product Code
- FCL FDA UDI
- EMDN Code
- G0308010101 GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Flexible endoscopic biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Flexible endoscopic biopsy forceps, single-use
Clear-Bite Biopsy Forceps by Finemedix Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic biopsy forceps, single-use.
- Disposable Biopsy Forceps — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class IIa
- Single Use Biopsy Forceps — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class I
- Disposable Endoscopic Biopsy Forceps — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- POWER-ENDO — Jiangsu Power-endo Medical Technology Co., Ltd · Class IIa
- Single Use Biopsy Forceps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Single-use Biopsy Forceps — Anrei Medical (HZ) CO., LTD. · Class IIa
- Disposable Biopsy Forceps — Jiangsu Ate Medical Technology Co., Ltd. · Class IIa
- Disposable Biopsy Forceps — Endoaccess GmbH · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (5)
- FDA UDI 0999bedf-b230-44ca-baf6-65900df9c4b7 34 fields · synced Jul 29, 2026
- FDA UDI cee07c58-9baf-4ded-beef-5d251658e148 34 fields · synced May 30, 2026
- EUDAMED 7d6a5ce6-1432-40e4-93b9-ef01932ec4ae 61 fields · synced Jul 13, 2026
- EUDAMED ea01a8c1-3010-41ce-ae2c-d2b7a9b6a18b 61 fields · synced Jul 14, 2026
- EUDAMED a4d20029-a6a3-4451-b1ab-5cdb00188a23 61 fields · synced Jul 29, 2026