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BGEcare Non-sterile Gauze Sponge
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 110S05-20
Identity
- Trade Name
- Sterile gauze swabs17 thread EUDAMEDBGEcare Non-sterile Gauze Sponge FDA UDI
- Generic Name
- Woven gauze pad, non-sterile FDA UDI
- Device Name
- gauze 13 threads in DOUBLE packaging sterile by ETO EUDAMEDBGEcare Non-sterile Gauze Sponge 2''X2'', 8-Ply, 200 pieces/pack,25 packs/carton box FDA UDI
- Model / Reference
- 110S05-20 EUDAMEDGS0102020820025NS FDA UDI
- Description
- BGEcare Non-sterile Gauze Sponge 2''X2'', 8-Ply, 200 pieces/pack,25 packs/carton box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972403300909 EUDAMEDFDA UDI
- Basic UDI-DI
- 697240330SGP000001SR EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- M0201010101 COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
- GMDN Term
- Woven gauze pad, non-sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Market of Registration
- France 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Woven gauze pad, non-sterile
BGEcare Non-sterile Gauze Sponge by Xuchang Zhende Surgical Dressing Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Xuchang Zhende Surgical Dressing Co., Ltd.
Sources (2)
- FDA UDI 90d1b375-1649-4caa-a55f-ae20e913b2fa 33 fields · synced Oct 6, 2026
- EUDAMED af366754-45a2-47e0-abe5-158e6248874e 61 fields · synced Jul 11, 2026