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Single Use Cytology Brushes
EUDAMEDFDA UDIClass I (EU MDR)
Ref MD-L-CB-1210-1006Ref MD-L-CB-3716-5010Ref MD-U-CB-2016-4008Ref MD-L-CB-2816-3010Ref MD-L-CB-2023-2010Ref MD-L-CB-2012-3010Ref MD-L-CB-1212-2006Ref MD-L-CB-3723-5010Ref MD-L-CB-2012-2010Ref MD-L-CB-2020-2010
Identity
- Trade Name
- Single Use Cytology Brushes EUDAMEDSingle Use Cytology Brush FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- Single Use Cytology Brushes EUDAMED
- Model / Reference
- MD-L-CB-1210-1006 EUDAMEDFDA UDIMD-L-CB-3716-5010 EUDAMEDMD-U-CB-2016-4008 EUDAMEDMD-L-CB-2816-3010 EUDAMEDMD-L-CB-2023-2010 EUDAMEDMD-L-CB-2012-3010 EUDAMEDMD-L-CB-1212-2006 EUDAMEDMD-L-CB-3723-5010 EUDAMEDMD-L-CB-2012-2010 EUDAMEDMD-L-CB-2020-2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942804700011 EUDAMED06942804700141 EUDAMED06942804700189 EUDAMED06942804700110 EUDAMED06942804700103 EUDAMED06942804700066 EUDAMED06942804700028 EUDAMED06970401810703 EUDAMEDFDA UDI06942804700165 EUDAMED06942804700059 EUDAMED06942804700097 EUDAMED
- Basic UDI-DI
- 69365343CBLrespiratoryQW EUDAMED69365343CBUrespiratory3E EUDAMED697040181CytologyBrushLP3 EUDAMED
- 510(k) Number
- K220063 FDA UDI
- FDA Product Code
- FDX FDA UDI
- EMDN Code
- R0799 BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER EUDAMEDG03080301 GASTROINTESTINAL CYTOLOGY, BRUSHES EUDAMED
- GMDN Term
- Flexible endoscopic cytology brush, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Single Use Cytology Brushes by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69365343CBLrespiratoryQW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000012417
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (12)
- EUDAMED 850ec2b3-278d-4a63-9097-5e9b8403d7f2 61 fields · synced Sep 18, 2026
- EUDAMED 6eb1a1b2-26e5-4c78-b299-48886c38e6be 61 fields · synced May 17, 2026
- EUDAMED cead0939-c7ee-4547-9658-fcb54b37aa85 61 fields · synced May 17, 2026
- EUDAMED 7162c703-50be-496f-93f0-3c4e6f1c59c5 61 fields · synced May 17, 2026
- EUDAMED e2a4085b-c6ea-42bd-97a5-9980ef57bf93 61 fields · synced May 18, 2026
- EUDAMED 05862268-b287-431e-ba0c-fd2cf4a982e4 61 fields · synced May 18, 2026
- EUDAMED 3eff49ee-abc5-42ae-beca-89bb1c2e56f0 61 fields · synced May 19, 2026
- EUDAMED 919f067e-770f-4e76-8bd9-bcfa50d2bfb3 61 fields · synced May 19, 2026
- EUDAMED 4492e0cc-3f84-4527-9408-80fa1e9aebc3 61 fields · synced May 19, 2026
- EUDAMED 542ef143-93fb-450c-8d8d-470895e01085 61 fields · synced May 19, 2026
- EUDAMED 5265a600-1b68-4bd5-a443-65156a6e582c 61 fields · synced May 19, 2026
- FDA UDI e70ef7cf-1e3e-412e-a9af-1e0f62e8aa95 33 fields · synced May 30, 2026