← Back to catalogue
DC-Air® Intraoral Sensor Holders
EUDAMEDFDA UDIClass I (EU MDR)
Ref DC-HP-1
by Athlos Oy
Identity
- Trade Name
- DC-Air® Intraoral Sensor Holders EUDAMEDDC-Air™ Holder Pack FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Intraoral sensor holder kit EUDAMEDDC-Air™ Holder Pack is intended to position and to hold x-ray sensor inside the mouth of the patient. FDA UDI
- Model / Reference
- DC-HP-1 EUDAMEDFDA UDI
- Description
- DC-Air™ Holder Pack is intended to position and to hold x-ray sensor inside the mouth of the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06429810587145 EUDAMEDFDA UDI
- Basic UDI-DI
- 6429810587DCHP019M EUDAMED
- FDA Product Code
- EGZ FDA UDI
- EMDN Code
- L15901199 POSITIONING INSTRUMENTS FOR DENTAL DEVICES, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental x-ray film holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.1905 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
DC-Air® Intraoral Sensor Holders by Athlos Oy — 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 | 6429810587DCHP019M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Athlos Oy
- EUDAMED SRN
- FI-MF-000021233
Sources (2)
- EUDAMED 9c40da10-0156-41d8-bca2-059652d781f5 61 fields · synced Jun 19, 2026
- FDA UDI 6b842c88-6030-4ff6-b820-0106ed07e2a9 33 fields · synced May 30, 2026