Identity
- Trade Name
- Tub Liner EUDAMED
- Device Name
- Non-Sterile Instrument Holders and Organizers Products EUDAMED
- Model / Reference
- 20Z462 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840161303271 EUDAMED
- Basic UDI-DI
- 08401613000233 EUDAMED
- EMDN Code
- V0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Surgical instrument/implant rack
Tub Liner by Zirc Dental Products, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/implant rack.
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class I
- VASSOIO GAMMAFIX DOI ROSA — MEDESY srl · Class I
- LOQTEQ® — aap Implantate AG · Class I
- 1208 — Siam intermagnate CO.,LTD. · Class I
- VASSOIO GAMMAFIX CINC AZZURRO — MEDESY srl · Class I
- Accessories, arthroscopic — PARCUS MEDICAL LLC · Class I
- SPIRECUT — Spirecut AG · Class I
- MATRIXWAVE — Synthes · Class I
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 | 08401613000233 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (1)
- EUDAMED 8f634b39-8ead-4ab9-8dc9-1c7e9257f185 61 fields · synced Aug 3, 2026