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Invisalign Pliers Set (Detail/Eraser)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 76018Model Invisalign Pliers
Identity
- Trade Name
- Invisalign Pliers Set (Detail/Eraser) EUDAMEDKit, Pliers Set Detail/Eraser FDA UDI
- Generic Name
- Orthodontic pliers FDA UDI
- Device Name
- Invisalign Pliers EUDAMEDOrthodontic Pliers FDA UDI
- Model / Reference
- Invisalign Pliers EUDAMED76018 EUDAMEDFDA UDI
- Description
- Orthodontic Pliers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021155 EUDAMED00816063021506 FDA UDI
- Basic UDI-DI
- 081606302PliersWK EUDAMED
- FDA Product Code
- JEX FDA UDI
- EMDN Code
- L150702 ORTHODONTIC PLIERS, REUSABLE EUDAMED
- GMDN Term
- Orthodontic pliers FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Invisalign Pliers Set (Detail/Eraser) by Align Technology, 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 | 081606302PliersWK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED e3609106-e631-42b8-aff8-74a6139dc0d9 61 fields · synced Jul 20, 2026
- FDA UDI 44bad3b8-2652-438e-ba39-b8c1e734b4fd 33 fields · synced May 30, 2026