Identity
- Trade Name
- Cellebrity™ EUDAMEDCellebrity FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- Cytology Brushes (Cellebrity) EUDAMEDEndoscopic Cytology Brush FDA UDI
- Model / Reference
- M00516150 EUDAMEDFDA UDI
- Description
- Endoscopic Cytology Brush FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729746331 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000371N6 EUDAMED
- FDA Product Code
- BTG FDA UDI
- EMDN Code
- R07020301 BRONCOPULMONARY CYTOLOGY BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Flexible endoscopic cytology brush, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 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
CMR Substance
Yes
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
No
FDA UDI
Cellebrity™ 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 | 01915060000000000000371N6 | 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 fab887a1-9a35-4242-930a-2f283a0fb49a 61 fields · synced Jun 19, 2026
- FDA UDI 8f8505fd-044c-4452-9b52-076752550141 34 fields · synced May 30, 2026