Identity
- Model / Reference
- TOR EUDAMED5227 EUDAMEDTLO EUDAMED5227_LAB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594019281 EUDAMED08445594002306 EUDAMED
- Basic UDI-DI
- 8445594_TORN_RECT_LQ EUDAMED8445594_TORN_LOCALIZ_DH EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMEDQ010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
Reusable
No
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
5227 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_RECT_LQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Em Exact, S.a.
- EUDAMED SRN
- ES-MF-000010830
Sources (2)
- EUDAMED 5e71e5ff-64e0-4a56-aecf-c355d4bebe2d 61 fields · synced Jul 12, 2026
- EUDAMED c3ac5b96-dfca-4821-872a-18b6b8f360e5 61 fields · synced May 18, 2026