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DCI II Manual Control Unit for 2HP, 1 Wet & 1 Dry
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4102
Identity
- Trade Name
- DCI FDA UDI
- Generic Name
- Dental delivery system instrument unit, pneumatic FDA UDI
- Device Name
- DCI II Manual Control Unit for 2HP, 1 Wet & 1 Dry EUDAMEDFDA UDI
- Model / Reference
- 4102 EUDAMEDFDA UDI
- Description
- DCI II Manual Control Unit for 2HP, 1 Wet & 1 Dry FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810021438979 EUDAMEDFDA UDI
- Basic UDI-DI
- 081002143UNITSZ8 EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental delivery system instrument unit, pneumatic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Belgium 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
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental delivery system
DCI II Manual Control Unit for 2HP, 1 Wet & 1 Dry by DCI International, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Dental delivery system.
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- 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
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 | 081002143UNITSZ8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DCI International, LLC
- EUDAMED SRN
- US-MF-000022306
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED faceb0a6-0009-4fd0-82d3-458e17656ce2 61 fields · synced Oct 6, 2026
- FDA UDI e9ba9a58-fb30-480d-a171-cab162e6224b 34 fields · synced May 30, 2026