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Micro Applicator Tips
EUDAMEDClass I (EU MDR)
Ref 922YRef 922LRef B922YRef 921BRef B921GRef B922LRef 921LRef G-921Ref 922BRef B921YRef B921BRef 921G
Identity
- Trade Name
- Micro Applicator Tips EUDAMED
- Device Name
- Applicators EUDAMED
- Model / Reference
- 922Y EUDAMED922L EUDAMEDB922Y EUDAMED921B EUDAMEDB921G EUDAMEDB922L EUDAMED921L EUDAMEDG-921 EUDAMED922B EUDAMEDB921Y EUDAMEDB921B EUDAMED921G EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125922Y2 EUDAMED+D125922L2 EUDAMED+D125B922Y2 EUDAMED+D125921B2 EUDAMED+D125B921G2 EUDAMED+D125B922L2 EUDAMED+D125921L2 EUDAMED+D125G9212 EUDAMED+D125922B2 EUDAMED+D125B921Y2 EUDAMED+D125B921B2 EUDAMED+D125921G2 EUDAMED
- Basic UDI-DI
- ++D125APPLICATORK8 EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Category: Dental material injection cannula, single-use
Micro Applicator Tips by Premium Plus (Dongguan) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental material injection cannula, single-use.
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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 | ++D125APPLICATORK8 | Class I | Active |
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Manufacturer
- Manufacturer
- Premium Plus (Dongguan) Limited
- EUDAMED SRN
- CN-MF-000038259
- Authorised Representative
- Premium Plus Poland sp. z o.o. PL-AR-000030110
Sources (12)
- EUDAMED bb140c14-0ecc-46e3-954c-d65b6db3d81a 61 fields · synced Sep 17, 2026
- EUDAMED 6e5ee0c8-bec7-4e08-a05a-fdf04bedf10f 61 fields · synced May 16, 2026
- EUDAMED dc0af14e-47f8-4c31-9757-545952ff81ac 61 fields · synced May 17, 2026
- EUDAMED 0fa29b8c-6365-4fd1-98b7-1c019f2beec3 61 fields · synced May 17, 2026
- EUDAMED 2d92e088-20e3-444b-890c-b08f99eee49d 61 fields · synced May 17, 2026
- EUDAMED effc3611-6fc6-4ab6-aa29-ce80863c8824 61 fields · synced May 17, 2026
- EUDAMED 44a9c552-595c-403b-98e7-01b52b6eecd0 61 fields · synced May 17, 2026
- EUDAMED 7493d1d6-a144-4f9b-8c3b-86f41a48a8fd 61 fields · synced May 17, 2026
- EUDAMED dbe1e404-3531-4bcc-bb3c-b6a4b61a3504 61 fields · synced May 18, 2026
- EUDAMED 90afb6c6-e408-45e1-b5f9-7ef01dc75121 61 fields · synced May 18, 2026
- EUDAMED 7a446919-36c0-4353-999e-e491bae10797 61 fields · synced May 18, 2026
- EUDAMED a947d8be-427e-4b4c-b773-30f38b622481 61 fields · synced May 18, 2026