Identity
- Trade Name
- EXEL ZORBAND BANDAGE, LARGE EUDAMEDEXEL ZORBAND BANDAGE, LARGE FDA UDI
- Generic Name
- Pressure bandage, Hevea-latex, single-use FDA UDI
- Device Name
- Pressure Bandage EUDAMEDEXEL ZORBAND BANDAGE, LARGE 100/BX, 1000/CS, 12CS/CRTN FDA UDI
- Model / Reference
- 26834 EUDAMEDFDA UDI
- Description
- EXEL ZORBAND BANDAGE, LARGE 100/BX, 1000/CS, 12CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26834 FDA UDI
- Primary DI / UDI-DI
- 00020221268348 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221268348 EUDAMED
- FDA Product Code
- KGX FDA UDIMHW FDA UDI
- EMDN Code
- H900102 BANDAGES FOR SUTURES EUDAMED
- GMDN Term
- Pressure bandage, Hevea-latex, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI880.5075 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Exel Zorband Bandage, Large by Exelint International, Co. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00020221268348 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 61c8102a-0c9b-4f53-b99f-f110f6341f64 61 fields · synced Oct 6, 2026
- FDA UDI 7f57839c-733b-4409-b09f-5c4f558498c0 35 fields · synced May 30, 2026