Identity
- Trade Name
- AccuFilm I EUDAMEDAccuFilm® FDA UDI
- Generic Name
- Dental articulation paper FDA UDI
- Device Name
- AccuFilm I & II EUDAMEDRed AccuFilm® I Single-Sided FDA UDI
- Model / Reference
- S015 EUDAMEDRed FDA UDI
- Description
- Red AccuFilm® I Single-Sided FDA UDI
Identifiers
- Catalog Number
- S015 FDA UDI
- Primary DI / UDI-DI
- 10810000526083 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052AFI&IICY EUDAMED
- Unit of Use DI
- 00810000526086 EUDAMED
- FDA Product Code
- EFH FDA UDI
- EMDN Code
- Q01020201 ARTICULATION PAPERS EUDAMED
- GMDN Term
- Dental articulation paper 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AccuFilm I 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 | 081000052AFI&IICY | 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 062382b5-dc40-42c0-b3ea-c68538cfe9ce 61 fields · synced Jul 9, 2026
- FDA UDI 3fd1edfa-f46f-481c-9840-ca86462c8e7d 35 fields · synced May 30, 2026