Identity
- Model / Reference
- TOD EUDAMEDLAN-BIRA1608HT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594025985 EUDAMED
- Basic UDI-DI
- 8445594_TORN_ORTO_QQ EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Lan-Bira1608ht by Em Exact, S.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8445594_TORN_ORTO_QQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Em Exact, S.a.
- EUDAMED SRN
- ES-MF-000010830
Sources (1)
- EUDAMED 4f798f6e-1a42-4145-9093-b1d90f2f8189 61 fields · synced Jun 18, 2026