← Back to catalogue
Endo Motors
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref N/AModel ZR AUTO MOTOR510(k) K222548Model ZR Touch,BR Rap,MR AUTO MOTOR,ZR-Rap,Endo Apex,Mini Apex,Wave Q,Ultra Dancer,ETC.
Identity
- Trade Name
- Endo Motors EUDAMEDZR AUTO MOTOR EUDAMED
- Device Name
- Endo Motors EUDAMED
- Model / Reference
- ZR AUTO MOTOR EUDAMEDN/A EUDAMEDZR Touch,BR Rap,MR AUTO MOTOR,ZR-Rap,Endo Apex,Mini Apex,Wave Q,Ultra Dancer,ETC. EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941422601854 EUDAMED
- Basic UDI-DI
- 69590742EndoMotors2S EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
Endo Motors by Shenzhen Perfect Medical Instruments Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Dental delivery system.
- Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
- V8 TOUCH — VITALI S.R.L. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222548 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69590742EndoMotors2S | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Perfect Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000025529
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 73a29409-08a8-43f6-ba83-afd39b9f1852 85 fields · synced Jul 13, 2026
- EUDAMED b537022f-fa6c-4c0a-a846-9b40dc326ea9 61 fields · synced Jul 13, 2026
- FDA 510(k) K222548 1 fields · synced May 18, 2026