Identity
- Trade Name
- Hemospray Endoscopic Hemostat EUDAMEDHemospray® Endoscopic Hemostat EUDAMEDHemospray FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- Hemospray Endoscopic Hemostat EUDAMEDFDA UDI
- Model / Reference
- HEMO-7 EUDAMEDG56572 FDA UDI
- Description
- HEMOSPRAY ENDOSCOPIC HEMOSTAT FDA UDI
Identifiers
- Catalog Number
- HEMO-7 FDA UDI
- Primary DI / UDI-DI
- 00827002565722 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000017MR EUDAMED
- FDA Product Code
- QAU FDA UDI
- EMDN Code
- G020499 GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER EUDAMED
- GMDN Term
- Non-organic haemostatic agent FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4456 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hemospray Endoscopic Hemostat by Wilson-Cook Medical, Inc. — Class IIb — 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 | 0827002WCM00000000017MR | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (3)
- EUDAMED 0f1503c3-dd05-44bd-8d7b-428ecae314df 61 fields · synced Oct 6, 2026
- FDA UDI 27ab7a14-9948-4f36-8aaa-21cec7fd90d8 36 fields · synced May 30, 2026
- EUDAMED dd8a79f3-56ba-4693-98f2-784d3e88d8aa 61 fields · synced Oct 5, 2026