Identity
- Trade Name
- BGEcare Sterile Non-woven Island Dressing FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- BGEcare Sterile Non-woven Island Dressing, 4''X4'', 1 pieces/pack, 50 packs/box, 12 boxes/carton box FDA UDI
- Model / Reference
- ID0404015012S FDA UDI
- Description
- BGEcare Sterile Non-woven Island Dressing, 4''X4'', 1 pieces/pack, 50 packs/box, 12 boxes/carton box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959385794308 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
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
Radiation Sterilization FDA UDI
Category: Synthetic polymer semi-permeable film dressing, adhesive
BGEcare Sterile Non-woven Island Dressing by Zhende Medical Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Zhende Medical Co., Ltd.
Sources (2)
- FDA UDI df894695-6d8b-4bc9-8d3b-39b1af5e0c54 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026