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Disposable Cervical Brush
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref CH4Ref B1Ref CH5Ref BD1Ref BK1Ref CH7Ref CH8Ref F2Ref CH2Ref D2Ref BE1Ref F1Ref BM1Ref D1Ref CH1Ref A1Ref BJ1Ref A2Ref C2Ref CH6
Identity
- Trade Name
- Disposable Cervical Brush EUDAMED
- Device Name
- Disposable Cervical Brush EUDAMED
- Model / Reference
- CH4 EUDAMEDB1 EUDAMEDCH5 EUDAMEDBD1 EUDAMEDBK1 EUDAMEDCH7 EUDAMEDCH8 EUDAMEDF2 EUDAMEDCH2 EUDAMEDD2 EUDAMEDBE1 EUDAMEDF1 EUDAMEDBM1 EUDAMEDD1 EUDAMEDCH1 EUDAMEDA1 EUDAMEDBJ1 EUDAMEDA2 EUDAMEDC2 EUDAMEDCH6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949717002935 EUDAMED06949717002706 EUDAMED06949717002942 EUDAMED06949717002829 EUDAMED06949717002874 EUDAMED06949717002966 EUDAMED06949717002973 EUDAMED06949717002812 EUDAMED06949717002904 EUDAMED06949717002799 EUDAMED06949717002836 EUDAMED06949717002805 EUDAMED06949717002881 EUDAMED06949717002782 EUDAMED06949717002898 EUDAMED06949717002652 EUDAMED06949717002867 EUDAMED06949717002676 EUDAMED06949717002775 EUDAMED06949717002959 EUDAMED
- Basic UDI-DI
- 69497170DCB1021GQ EUDAMED
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Disposable Cervical Brush by Ningbo HLS Medical Products Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141057 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69497170DCB1021GQ | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo HLS Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000026849
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (21)
- EUDAMED 524b5c6a-c29d-4ff5-88b3-6a338f75999a 61 fields · synced Oct 6, 2026
- EUDAMED 7b748582-6084-443f-b56c-bfef0adf3a47 61 fields · synced May 11, 2026
- EUDAMED 9a521187-4795-4b1b-8675-d39017aa56dc 61 fields · synced May 16, 2026
- EUDAMED 6746b2cb-1685-4ac6-ac5c-a7c1c98b6597 61 fields · synced May 17, 2026
- EUDAMED 25268fda-5c74-45e2-8d3d-f4f8ebe8304a 61 fields · synced May 17, 2026
- EUDAMED 9a1f14ae-8b44-4775-abe8-78f62402f5ef 61 fields · synced May 17, 2026
- EUDAMED 93917b9d-82ac-4d13-b71d-3efc925b8fd8 61 fields · synced May 17, 2026
- EUDAMED 12024ee7-88d8-4bbc-83dc-93b95d50eb4a 61 fields · synced May 17, 2026
- EUDAMED 649ce8da-ce39-46e9-a252-51ad4e591ffb 61 fields · synced May 17, 2026
- EUDAMED 65b41728-3aff-4eee-8ef3-059e40020e5a 61 fields · synced May 18, 2026
- EUDAMED 3d526ead-e1cf-494f-9d4f-8fbf725a7537 61 fields · synced May 18, 2026
- EUDAMED c9a8d629-a6e5-40c2-b6b7-bc1a8604e7ae 61 fields · synced May 18, 2026
- EUDAMED 44960af7-0759-491e-89c8-b43bbc9e5e66 61 fields · synced May 18, 2026
- EUDAMED d22ffce3-c55b-439e-b703-54e7e7a055a8 61 fields · synced May 18, 2026
- EUDAMED 1f77c12a-a088-47ad-9fb0-6f4966932d34 61 fields · synced May 18, 2026
- EUDAMED 907e9bd8-fe36-41ad-bedb-346550f4b07f 61 fields · synced May 18, 2026
- EUDAMED e1edcb7a-9faf-4637-a45f-43d3ae613810 61 fields · synced May 18, 2026
- EUDAMED 2a30ea18-f4a2-491f-bdec-db04d04d56a3 61 fields · synced May 19, 2026
- EUDAMED 159759a6-98bc-4c73-9562-b053b057bb4c 61 fields · synced May 19, 2026
- EUDAMED 7bd7114f-d41c-4c71-9fbc-b56f57d17520 61 fields · synced May 19, 2026
- FDA 510(k) K141057 1 fields · synced May 18, 2026