Identity
- Trade Name
- Dental Unit EUDAMEDDental chair and accessories FDA UDI
- Generic Name
- Dental chair, mechanical FDA UDI
- Device Name
- Dental Unit EUDAMEDDental chair and accessories FDA UDI
- Model / Reference
- S600 EUDAMEDFDA UDI
- Description
- Dental chair and accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971119541880 EUDAMEDFDA UDI
- Basic UDI-DI
- 697111954AXXR2 EUDAMED
- Direct Marketing DI
- 06971119541880 EUDAMED
- FDA Product Code
- NRU FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental chair, mechanical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6250 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental delivery system
Dental Unit by Guangdong JINME Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental delivery system.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697111954AXXR2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangdong JINME Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033806
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 533a2c11-737f-4835-b95c-6e567833e76d 61 fields · synced Jul 14, 2026
- FDA UDI 12e989fd-f36f-4e58-ba93-62c75742b6d3 33 fields · synced May 24, 2026