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Aseptico Portable Dental Chairs
EUDAMEDFDA UDIClass I (EU MDR)
Ref ADC-01P-REDModel ADC-01 / ADC-02
Identity
- Trade Name
- Aseptico Portable Dental Chairs EUDAMEDAseptico FDA UDI
- Generic Name
- Dental chair, mechanical FDA UDI
- Device Name
- Aseptico Portable Dental Chairs EUDAMEDPortable Pediatric Dental Chair FDA UDI
- Model / Reference
- ADC-01 / ADC-02 EUDAMEDADC-01P-RED EUDAMEDFDA UDI
- Description
- Portable Pediatric Dental Chair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817417021453 EUDAMEDFDA UDI
- Basic UDI-DI
- 081741702portablechairsVM EUDAMED
- FDA Product Code
- NRU FDA UDI
- EMDN Code
- V080202 MANUAL MEDICAL CHAIRS EUDAMED
- GMDN Term
- Dental chair, mechanical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6250 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Aseptico Portable Dental Chairs by Aseptico, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081741702portablechairsVM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
- EUDAMED SRN
- US-MF-000014012
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 5d914a00-73cb-4c04-959f-8ade1f1c82cd 61 fields · synced Jun 18, 2026
- FDA UDI 4a74f334-3aad-4ce9-8cc7-4f68f0d64c29 34 fields · synced May 30, 2026