Identity
- Trade Name
- EXEL ZORBAND BANDAGE, EX-LARGE EUDAMEDFDA UDIEXEL ZorBand Pressure Bandages, Extra Large EUDAMED
- Generic Name
- Pressure bandage, Hevea-latex, single-use FDA UDI
- Device Name
- Pressure Bandage EUDAMEDEXEL ZorBand Pressure Bandages EUDAMEDEXEL ZORBAND BANDAGE, EX-LARGE 100/BX, 1,000/CS, 12CS/CRTN FDA UDI
- Model / Reference
- 26836 EUDAMEDFDA UDI
- Description
- EXEL ZORBAND BANDAGE, EX-LARGE 100/BX, 1,000/CS, 12CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26836 FDA UDI
- Primary DI / UDI-DI
- 00020221268362 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221268362 EUDAMED20221WNDRS268C3 EUDAMED
- FDA Product Code
- KGX FDA UDIMHW FDA UDI
- EMDN Code
- H900102 BANDAGES FOR SUTURES EUDAMEDM04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD 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 EUDAMEDAustria 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
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
Exel Zorband Bandage, Ex-Large by Exelint International, Co. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221268362 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00020221268362 | 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 (3)
- EUDAMED 79b170f8-2b18-4ebb-9dba-45c22ed8648d 61 fields · synced Oct 6, 2026
- FDA UDI e3b81e50-431e-4a2c-87c4-9a037cf44605 35 fields · synced May 30, 2026
- EUDAMED 01a9df36-1827-49ca-be65-7cb01d9ae1e3 61 fields · synced Jul 15, 2026