Identity
- Trade Name
- Hedgehog™ EUDAMEDHedgehog FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- Hedgehog Cleaning Brushes EUDAMEDCleaning Brushes, Double Bundle, Double-End Brush Plus Valve Brush FDA UDI
- Model / Reference
- SBB-382 EUDAMEDFDA UDI
- Description
- Cleaning Brushes, Double Bundle, Double-End Brush Plus Valve Brush FDA UDI
Identifiers
- Catalog Number
- SBB-382 FDA UDI
- Primary DI / UDI-DI
- 00840253114020 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000035MK EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- G03080399 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - OTHER EUDAMED
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Hedgehog™ by Boston Scientific Corporation — 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 | 01915060000000000000035MK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 2bd128d9-adc5-45a0-96ad-42a5f8413fa0 61 fields · synced Jun 19, 2026
- FDA UDI 762eb854-accc-487b-a30a-d349ec183573 34 fields · synced May 25, 2026