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Novacryl
EUDAMEDClass IIa (EU MDR)
Ref 82280 CEModel Self-curing polymer Incisal color Novacryl CE 40gRef 82258 CEModel Self-curing polymer A2 color Novacryl CE 10kgRef 82225 CEModel Self-curing polymer A3.5 color Novacryl 40g
by Productora Y Comercializadora Odontologica New Stetic S.a
Identity
- Trade Name
- Novacryl EUDAMED
- Device Name
- SELF-CURING ACRYLIC RESINS EUDAMED
- Model / Reference
- Self-curing polymer Incisal color Novacryl CE 40g EUDAMED82280 CE EUDAMEDSelf-curing polymer A2 color Novacryl CE 10kg EUDAMED82258 CE EUDAMEDSelf-curing polymer A3.5 color Novacryl 40g EUDAMED82225 CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07701126633532 EUDAMED07701126633235 EUDAMED07701126633587 EUDAMED
- Basic UDI-DI
- 7701126633532XD EUDAMED7701126633235X4 EUDAMED7701126633587Y6 EUDAMED
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Partial denture
Novacryl by Productora Y Comercializadora Odontologica New Stetic S A — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Partial denture.
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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 | 7701126633532XD | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CO-MF-000036727
- Authorised Representative
- Ranelagh Capital SLU ES-AR-000040175
Sources (3)
- EUDAMED 2c9632e3-2dac-43ca-8b48-6a009e933853 61 fields · synced Oct 6, 2026
- EUDAMED a2270e86-b791-4475-8cce-d14fd8331f5f 61 fields · synced May 17, 2026
- EUDAMED 3639fd3d-d7c6-4e2e-86ab-f937a7b3ce34 61 fields · synced May 18, 2026