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BGEcare Non-sterile Gauze Sponge
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref PSM5034Ref PSM5057
Identity
- Trade Name
- GAUZE DRESSING NON-STERILE EUDAMEDBGEcare Non-sterile Gauze Sponge FDA UDI
- Generic Name
- Woven gauze pad, non-sterile FDA UDI
- Device Name
- Non sterile gauze swab 40s 26x18 EUDAMEDBGEcare Non-sterile Gauze Sponge 2''X2'', 12-Ply,200 pieces/pack, 40 packs/carton box FDA UDI
- Model / Reference
- PSM5034 EUDAMEDPSM5057 EUDAMEDGS0102021220040NS FDA UDI
- Description
- BGEcare Non-sterile Gauze Sponge 2''X2'', 12-Ply,200 pieces/pack, 40 packs/carton box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06978419028523 EUDAMED06978419028615 EUDAMED06972403300923 FDA UDI
- Basic UDI-DI
- 697240330GP0000014T EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
- GMDN Term
- Woven gauze pad, non-sterile FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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 (3)
- FDA UDI 9b4eaf20-e4ce-4dfd-ae52-5ce4feb026cb 33 fields · synced Oct 6, 2026
- EUDAMED 9c3efb92-5ca6-4c9a-a814-da90de861dc2 61 fields · synced Jul 10, 2026
- EUDAMED c49b2fae-4959-412b-8bdb-5d9637cf80c8 61 fields · synced Jul 31, 2026