← Back to catalogue
Bl-42a
EUDAMEDClass I (EU MDR)
Ref 3015531303Model BL-40, BL-42A, BL-42B, BL-42C, BL-42D, BL-42E, BL-42F, BL-42G, BL-42H
Identity
- Trade Name
- BL-42A EUDAMED
- Device Name
- Micro Applicators EUDAMED
- Model / Reference
- BL-40, BL-42A, BL-42B, BL-42C, BL-42D, BL-42E, BL-42F, BL-42G, BL-42H EUDAMED3015531303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975617285031 EUDAMED
- Basic UDI-DI
- 697561728BRUSHT5 EUDAMED
- EMDN Code
- Q010506 PASTE APPLICATORS, 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-42a 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
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhaoqing Gaoyao Recende Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000028095
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5d469d27-ed00-4c0b-be3c-cb589b58ee57 61 fields · synced Jul 29, 2026