Identity
- Trade Name
- My LM-Activator 40 Low Long EUDAMEDLMDental FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- Removable orthodontic appliance EUDAMEDMy LM-Activator 40 Low Long FDA UDI
- Model / Reference
- 94440LL EUDAMEDFDA UDI
- Description
- My LM-Activator 40 Low Long FDA UDI
Identifiers
- Catalog Number
- 94440LL FDA UDI
- Primary DI / UDI-DI
- 06438311231433 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311ROA10UU EUDAMED
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Market of Registration
- Finland 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
My LM-Activator 40 Low Long by LM-Instruments 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 | 6438311ROA10UU | 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
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED 783e43f3-3c0b-4fcf-99c9-ae4b91663508 61 fields · synced Jul 21, 2026
- FDA UDI 23c7f61e-af98-4d39-b81c-b93f94ddbfc8 34 fields · synced May 30, 2026