Identity
- Trade Name
- Koala™ EUDAMEDFDA UDI
- Generic Name
- Medical device cleaning sponge/set FDA UDI
- Device Name
- Koala Cleaning Sponge EUDAMEDCleaning Sponge FDA UDI
- Model / Reference
- M00501762 EUDAMEDFDA UDI
- Description
- Cleaning Sponge FDA UDI
Identifiers
- Catalog Number
- M00501762 FDA UDI
- Primary DI / UDI-DI
- 00191506043636 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000027ML EUDAMED
- Unit of Use DI
- 00191506043629 EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Medical device cleaning sponge/set 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
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
Category: Gastro-urological guidewire, single-use
Koala™ by Boston Scientific Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 01915060000000000000027ML | 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 16884051-cb27-4694-9cd4-441acb1e69b2 61 fields · synced Jun 19, 2026
- FDA UDI d5827072-0b7a-434a-b03c-493e740be53c 34 fields · synced May 30, 2026