Identity
- Model / Reference
- TLO EUDAMED5132_LAB EUDAMEDTOR EUDAMED5132 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594002412 EUDAMED08445594017652 EUDAMED
- Basic UDI-DI
- 8445594_TORN_LOCALIZ_DH EUDAMED8445594_TORN_RECT_LQ EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMEDP01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMEDEUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
Category: Dental implant suprastructure, temporary, preformed, single-use
5132_lab by Em Exact, S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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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_LOCALIZ_DH | Class I | Active |
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Manufacturer
- Manufacturer
- Em Exact, S.a.
- EUDAMED SRN
- ES-MF-000010830
Sources (2)
- EUDAMED 4f18681a-424b-4dc2-a819-fe80119dece5 61 fields · synced Jul 20, 2026
- EUDAMED 22d45114-ff27-4e5c-b2b2-eb4dc583af6d 61 fields · synced May 18, 2026