Identity
- Trade Name
- UM-1L EUDAMED
- Device Name
- Handpiece of Ultrasonic Scaler EUDAMED
- Model / Reference
- UM-1L EUDAMED6680900 EUDAMED6680035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877803230 EUDAMED06972597782338 EUDAMED
- Basic UDI-DI
- 697259778ES004NY EUDAMED
- Direct Marketing DI
- 06941877803230 EUDAMED06972597782338 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMEDItaly 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 delivery system
Um-1l by Changzhou Sifary Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697259778ES004NY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 3553b2c9-2476-43ba-b181-aa247465fb48 61 fields · synced Jul 26, 2026
- EUDAMED ff1a5f07-fe16-4812-8dd0-9c74c2686edd 61 fields · synced Jul 8, 2026