Identity
- Model / Reference
- PSC EUDAMED8201 EUDAMEDTOD EUDAMEDLAN-BIRA2921T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594012190 EUDAMED08445594026340 EUDAMED
- Basic UDI-DI
- 8445594_PILAR_SOB_COCR_5D EUDAMED8445594_TORN_ORTO_QQ EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMEDQ010499 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
8201 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_PILAR_SOB_COCR_5D | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Em Exact, S.a.
- EUDAMED SRN
- ES-MF-000010830
Sources (2)
- EUDAMED 6936446e-dae6-4bb2-985d-febb075455d6 61 fields · synced Jul 18, 2026
- EUDAMED 4171995b-b90b-4b94-8201-5575b917a6e8 61 fields · synced May 18, 2026