Identity
- Trade Name
- Maxtaping A+ EUDAMEDFDA UDI
- Generic Name
- Pressure bandage, non-latex, single-use FDA UDI
- Device Name
- TAPES EUDAMEDMaxtaping A+, 14cm, 10 sheets FDA UDI
- Model / Reference
- 8095-BG-S EUDAMEDFDA UDI
- Description
- Maxtaping A+, 14cm, 10 sheets FDA UDI
Identifiers
- Catalog Number
- 8095 FDA UDI
- Primary DI / UDI-DI
- 00840270627466 EUDAMEDFDA UDI
- Basic UDI-DI
- 08402706CL1114N EUDAMED
- FDA Product Code
- KOX FDA UDI
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
- GMDN Term
- Pressure bandage, non-latex, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4730 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 14 Centimeter FDA UDI
Maxtaping A+ by OPPO Medical Inc. — 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 | 08402706CL1114N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OPPO Medical Inc.
- EUDAMED SRN
- US-MF-000005202
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 436ad5ea-20df-4fdf-8f0d-4b9da7809a18 61 fields · synced Jun 20, 2026
- FDA UDI 0cc85d2e-a1de-4599-8297-94bcdfd29202 36 fields · synced May 30, 2026