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Premium Line
EUDAMEDClass IIa (EU MDR)
Ref 661-0272-100Ref 661-0182-000Ref 661-0641-000Ref 661-0361-000Ref 661-0352-000Ref 661-1251-100Ref 661-0282-000Ref 661-0201-100Ref 661-0191-000Ref 661-0312-000Ref 661-0171-000Ref 661-0271-000Ref 661-0281-100Ref 480-1240-100Ref 661-0352-100Ref 661-1242-100Ref 661-0322-100Ref 661-0361-100Ref 661-0271-100Ref 480-0360-100Ref 661-0272-000Ref 480-0320-100Ref 661-0321-100Ref 661-0202-100Ref 480-0270-100Ref 661-0172-000Ref 480-0180-000Ref 661-0642-000Ref 661-0162-000Ref 661-0191-100Ref 661-0282-100Ref 480-0350-100
Identity
- Trade Name
- Premium Line EUDAMED
- Device Name
- Orthodontic Brackets and Buttons EUDAMED
- Model / Reference
- 661-0272-100 EUDAMED661-0182-000 EUDAMED661-0641-000 EUDAMED661-0361-000 EUDAMED661-0352-000 EUDAMED661-1251-100 EUDAMED661-0282-000 EUDAMED661-0201-100 EUDAMED661-0191-000 EUDAMED661-0312-000 EUDAMED661-0171-000 EUDAMED661-0271-000 EUDAMED661-0281-100 EUDAMED480-1240-100 EUDAMED661-0352-100 EUDAMED661-1242-100 EUDAMED661-0322-100 EUDAMED661-0361-100 EUDAMED661-0271-100 EUDAMED480-0360-100 EUDAMED661-0272-000 EUDAMED480-0320-100 EUDAMED661-0321-100 EUDAMED661-0202-100 EUDAMED480-0270-100 EUDAMED661-0172-000 EUDAMED480-0180-000 EUDAMED661-0642-000 EUDAMED661-0162-000 EUDAMED661-0191-100 EUDAMED661-0282-100 EUDAMED480-0350-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D82966102721009L EUDAMED+D82966101820009K EUDAMED+D82966106410009K EUDAMED+D82966103610009J EUDAMED+D82966103520009J EUDAMED+D82966112511009J EUDAMED+D82966102820009L EUDAMED+D82966102011009D EUDAMED+D82966101910009K EUDAMED+D82966103120009F EUDAMED+D82966101710009I EUDAMED+D82966102710009J EUDAMED+D82966102811009L EUDAMED+D82948012401009G EUDAMED+D82966103521009K EUDAMED+D82966112421009J EUDAMED+D82966103221009H EUDAMED+D82966103611009K EUDAMED+D82966102711009K EUDAMED+D82948003601009I EUDAMED+D82966102720009K EUDAMED+D82948003201009E EUDAMED+D82966103211009G EUDAMED+D82966102021009E EUDAMED+D82948002701009I EUDAMED+D82966101720009J EUDAMED+D82948001800009H EUDAMED+D82966106420009L EUDAMED+D82966101620009I EUDAMED+D82966101911009L EUDAMED+D82966102821009M EUDAMED+D82948003501009H EUDAMED
- Basic UDI-DI
- ++D829001001PBREM EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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: Orthodontic tube
Premium Line by EC Certification Service GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
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- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
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- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
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- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
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 | ++D829001001PBREM | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EC Certification Service GmbH
- EUDAMED SRN
- AT-MF-000006655
Sources (32)
- EUDAMED 2e71f0a1-7eb9-4bc1-b3a1-6074d7b9e538 61 fields · synced Oct 6, 2026
- EUDAMED 3be5bde2-d3fb-492a-80f9-30b4f5e01c47 61 fields · synced May 11, 2026
- EUDAMED 5f7d3eed-0baf-49f9-a3aa-42e9a3dc1377 61 fields · synced May 11, 2026
- EUDAMED d5931f2a-64e6-4b51-af9a-61384beca582 61 fields · synced May 16, 2026
- EUDAMED 519eee58-1dbf-486e-be3a-be0d409343fd 61 fields · synced May 16, 2026
- EUDAMED 2f75ed51-b32f-42b7-a2ae-4c43d9d36eae 61 fields · synced May 16, 2026
- EUDAMED f0031921-8f3b-4a84-ae4a-d1aaa740aacb 61 fields · synced May 16, 2026
- EUDAMED 30f9929b-85e4-4776-9560-deba2d218d3a 61 fields · synced May 16, 2026
- EUDAMED 5b8ea679-cb81-48f7-bb1f-d02b08da648d 61 fields · synced May 16, 2026
- EUDAMED 2e5a886d-1649-4fa3-9a19-ec5239bce39b 61 fields · synced May 16, 2026
- EUDAMED 650da7cc-6ec5-41d8-a489-b5905e27cdc9 61 fields · synced May 17, 2026
- EUDAMED 35bb547b-6f07-4eb0-b6c7-82afea75622b 61 fields · synced May 17, 2026
- EUDAMED 7b1e769e-8338-4c33-aa87-e15640489120 61 fields · synced May 17, 2026
- EUDAMED 06a37eb2-609c-45bc-b087-e5c9573a3a4e 61 fields · synced May 17, 2026
- EUDAMED 215e3607-8cf5-49b8-b1e4-8ad946b0c653 61 fields · synced May 17, 2026
- EUDAMED 4ef18eae-9089-41b1-9c2b-6214cfbfcf1b 61 fields · synced May 17, 2026
- EUDAMED e5525342-e5cd-4a0d-9f72-723dababf099 61 fields · synced May 17, 2026
- EUDAMED 50d57d47-b035-4889-ae89-6f34b77812ee 61 fields · synced May 18, 2026
- EUDAMED 85e1f82c-9cc8-4e46-b28c-ae7ee5051ab6 61 fields · synced May 18, 2026
- EUDAMED 8c082b91-185f-494a-b96b-0d79a65ce4fe 61 fields · synced May 18, 2026
- EUDAMED e77c4b44-3df4-48b9-9e72-aa9f87f8d3ba 61 fields · synced May 18, 2026
- EUDAMED 5d29b960-1f95-40bb-ac17-4d03e3fd9e3b 61 fields · synced May 18, 2026
- EUDAMED 3263f612-2aca-4ecb-8b75-2c11199403a2 61 fields · synced May 18, 2026
- EUDAMED e76c52b8-0ea5-4992-b96a-e9e9ceb60e3e 61 fields · synced May 18, 2026
- EUDAMED 742eb0b7-f3dd-45bb-b50d-8b5c4d7cdf39 61 fields · synced May 18, 2026
- EUDAMED 7f61f2f1-2bf7-4d4e-a1b6-df07bd99bba2 61 fields · synced May 18, 2026
- EUDAMED cfe35c15-80cc-498f-a657-19b0e5c82c96 61 fields · synced May 18, 2026
- EUDAMED a12fffa5-ee83-45e0-a280-41072fc1d48f 61 fields · synced May 19, 2026
- EUDAMED d7abf11b-1d25-46c1-af2b-6c5c60e1e193 61 fields · synced May 19, 2026
- EUDAMED c435d383-0545-4162-b4d0-800939e915b4 61 fields · synced May 19, 2026
- EUDAMED 7d9a0c45-0c90-4ffb-8ec1-5e033252a3f9 61 fields · synced May 19, 2026
- EUDAMED 34393f26-69da-4366-a9df-db370f1f7bc0 61 fields · synced May 19, 2026