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Bl-42
EUDAMEDClass I (EU MDR)
Ref 3015531303Model BL-40, BL-42A, BL-42B, BL-42C, BL-42D, BL-42E, BL-42F, BL-42G, BL-42HModel BL-42,BL-42D,BL-42F,BL-42M,BL-42G,BL-42GM,BL-42S,BL-42XS,BL-42P,BL-42PS,BL-42PXS,
Identity
- Trade Name
- BL-42 EUDAMEDBL-42XS EUDAMEDBL-42PS EUDAMED
- Device Name
- Micro Applicators EUDAMEDProphy Brush / Prophy Cup EUDAMED
- Model / Reference
- BL-40, BL-42A, BL-42B, BL-42C, BL-42D, BL-42E, BL-42F, BL-42G, BL-42H EUDAMED3015531303 EUDAMEDBL-42,BL-42D,BL-42F,BL-42M,BL-42G,BL-42GM,BL-42S,BL-42XS,BL-42P,BL-42PS,BL-42PXS, EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975617285024 EUDAMED06975617287493 EUDAMED06975617287516 EUDAMED
- Basic UDI-DI
- 697561728BRUSHT5 EUDAMED697561728PROPHY4S EUDAMED
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMEDQ010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental material mixing nozzle
Bl-42 by Zhaoqing Gaoyao Recende Medical Equipment Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental material mixing nozzle.
- Adhesive Tip Applicator — Huanghua Promisee Dental Co.Ltd. · Class I
- 3.2 Mixing Tips with Integrated Needle 25-Pack — Den-Mat Holdings, LLC · Class I
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- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Imprint™ 4 Regular — 3M Deutschland GmbH · Class II
- Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- #1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
- Plasdent — PLASDENT CORP. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697561728BRUSHT5 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhaoqing Gaoyao Recende Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000028095
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 50702ad6-cfc3-46d2-8c4c-2e7479fc773e 61 fields · synced Oct 6, 2026
- EUDAMED bbccb656-05c6-4b2a-bd63-b4d609037686 61 fields · synced May 17, 2026
- EUDAMED b5ace28f-fec1-4f61-83f9-1156600a8bdd 61 fields · synced May 18, 2026