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Articulating Film
EUDAMEDFDA UDIClass I (EU MDR)
Ref TPPModel Articulating Paper
Identity
- Trade Name
- Articulating Film EUDAMEDArticulating Fim FDA UDI
- Generic Name
- Dental articulation paper FDA UDI
- Device Name
- Articulating Fim, Blue Thin Precisely True, 0.0005"/13µm FDA UDI
- Model / Reference
- Articulating Paper EUDAMEDTPP EUDAMEDFDA UDI
- Description
- Articulating Fim, Blue Thin Precisely True, 0.0005"/13µm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224001842 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224ArticulatingMat6B EUDAMED
- Unit of Use DI
- 00732224001845 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Articulating Film by Crosstex International, 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 | 0732224ArticulatingMat6B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2d4e48f9-0199-43cd-89de-c5945f2baf4d 61 fields · synced Jul 18, 2026
- FDA UDI db35805d-ea35-4e9a-9fc6-5f4abe217076 34 fields · synced May 30, 2026