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Dental Retractor
EUDAMEDClass I (EU MDR)
Ref /Model CR01L,CR01S,CR02L,CR02M,CR02S,CR03,CR03L,CR03M,CR03S,CR04,CR04L,CR04S,CR05,CR05L,CR05S,CR06,CR07,CR09,CR09L,CR09M,CR09S,CR11L,CR11M,CR11S,CR12L,CR12M,CR12S,CR10,CR10M,CR10S,CR08,CR08L,CR08S,CR0802L,CR0802S,MP01,MP01L,MP01M,MP01S,MP02,MP02L,MP02M,MP02SRef CR13LRef CR10MRef CR03MRef CR04S
Identity
- Trade Name
- Dental Retractor EUDAMED
- Device Name
- Dental Retractor EUDAMED
- Model / Reference
- CR01L,CR01S,CR02L,CR02M,CR02S,CR03,CR03L,CR03M,CR03S,CR04,CR04L,CR04S,CR05,CR05L,CR05S,CR06,CR07,CR09,CR09L,CR09M,CR09S,CR11L,CR11M,CR11S,CR12L,CR12M,CR12S,CR10,CR10M,CR10S,CR08,CR08L,CR08S,CR0802L,CR0802S,MP01,MP01L,MP01M,MP01S,MP02,MP02L,MP02M,MP02S EUDAMED/ EUDAMEDCR13L EUDAMEDCR10M EUDAMEDCR03M EUDAMEDCR04S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000359 EUDAMED06954454002001 EUDAMED06954454006429 EUDAMED06954454002827 EUDAMED06954454002841 EUDAMED06954454002834 EUDAMED06954454000953 EUDAMED06954454000335 EUDAMED06954454000946 EUDAMED06954454000298 EUDAMED06954454000120 EUDAMED06954454013489 EUDAMED06954454006252 EUDAMED06954454005019 EUDAMED06954454000342 EUDAMED
- Basic UDI-DI
- 69544540DERE001M3 EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDSpain EUDAMEDAustria EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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: Gingival retraction cord, non-medicated
Dental Retractor by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gingival retraction cord, non-medicated.
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- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · 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 | 69544540DERE001M3 | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (18)
- EUDAMED 0d4b6641-7499-4cf8-93ec-626b41089720 61 fields · synced Oct 9, 2026
- EUDAMED ca80cd7d-aa7c-4710-a672-c252f9c277e5 61 fields · synced May 16, 2026
- EUDAMED 7616ac11-a54e-4971-be6a-c81be1bf1042 61 fields · synced May 16, 2026
- EUDAMED 5f37e647-3afc-49e1-9467-1f3b5df3c61d 61 fields · synced May 17, 2026
- EUDAMED 01b60185-fc18-42e3-832b-2e890bb62c53 61 fields · synced May 17, 2026
- EUDAMED 40a5d8bd-64a5-42c8-875d-48ca762f0510 61 fields · synced May 17, 2026
- EUDAMED 54bd1ffb-8889-48b4-bcd7-8bb2fe253fd7 61 fields · synced May 17, 2026
- EUDAMED 7faf7f62-f1cf-4e04-8dca-3408f3ffb1e3 61 fields · synced May 17, 2026
- EUDAMED 9b4d02c7-55ba-4e51-9aed-82c021be8add 61 fields · synced May 18, 2026
- EUDAMED 809ed398-aa3f-4011-ae67-229f074d8662 61 fields · synced May 18, 2026
- EUDAMED 86bcae85-2b9f-4d20-8a74-86b85493c4fa 61 fields · synced May 18, 2026
- EUDAMED 78ea2a75-bbfc-4bc5-90cf-39b7783315db 61 fields · synced May 18, 2026
- EUDAMED 7b6a7dea-0ebb-4736-a205-cc4ad2ee814a 61 fields · synced May 18, 2026
- EUDAMED f0d2f613-039c-4ff1-999a-e7448a51896b 61 fields · synced May 18, 2026
- EUDAMED 3992cb4a-67ac-4f2a-893b-ac682a884e2c 61 fields · synced May 19, 2026
- EUDAMED b055fba1-054c-41b8-85c1-75c9af4c602f 61 fields · synced Oct 8, 2026
- EUDAMED e5ad0748-4802-4d8e-a170-bf6b593680b1 61 fields · synced Oct 8, 2026
- EUDAMED 9992ee12-a18a-434d-920d-0f1ada35d547 61 fields · synced Oct 9, 2026