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Microporous Tape
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7759673Model A-Nonwoven, B-Silk, C-PE, D-Cotton
Identity
- Trade Name
- MICROPOROUS TAPE EUDAMEDHualian FDA UDI
- Generic Name
- Adhesive bandage FDA UDI
- Device Name
- Medical Tape EUDAMEDAdhesive Bandage FDA UDI
- Model / Reference
- A-Nonwoven, B-Silk, C-PE, D-Cotton EUDAMED7759673 EUDAMEDHLPL002 FDA UDI
- Description
- Adhesive Bandage FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16941762600255 EUDAMEDFDA UDI
- Basic UDI-DI
- 69417626002UX EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
- GMDN Term
- Adhesive bandage FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Ireland 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
No
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
Dimensions & Sizes
- Size
- Length — 76 Millimeter FDA UDIWidth — 25 Millimeter FDA UDI
Microporous Tape by Changzhou Hualian Health Dressing Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69417626002UX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Changzhou Hualian Health Dressing Co., Ltd.
- EUDAMED SRN
- CN-MF-000021134
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED d37cde62-2299-44e7-9415-63b799ada06c 61 fields · synced Oct 6, 2026
- FDA UDI db389100-3b6f-4fbc-81f9-13a4355f3fde 35 fields · synced May 26, 2026