Identity
- Trade Name
- AccuFilm EUDAMEDAccuFilm® FDA UDI
- Generic Name
- Dental articulation paste/solution FDA UDI
- Device Name
- AccuFilm IV EUDAMEDAccuFilm® IV Brush-On Marking Liquid FDA UDI
- Model / Reference
- S020 EUDAMEDFDA UDI
- Description
- AccuFilm® IV Brush-On Marking Liquid FDA UDI
Identifiers
- Catalog Number
- S020 FDA UDI
- Primary DI / UDI-DI
- 00810000526116 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052AFS020D6 EUDAMED
- FDA Product Code
- EFH FDA UDI
- EMDN Code
- Q01020202 SPRAY AND LIQUID DENTAL CONTACT INDICATORS EUDAMED
- GMDN Term
- Dental articulation paste/solution FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6140 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AccuFilm by Parkell, 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 | 081000052AFS020D6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED ad766bc0-255d-4fae-9b84-def085dcdb03 61 fields · synced Jun 20, 2026
- FDA UDI e907bb3f-ef36-4978-830c-6192e3e5ee60 36 fields · synced May 30, 2026