Identity
- Trade Name
- OPT ø6x70º AUT. Great Magnification EUDAMED
- Device Name
- RIGID ENDOSCOPE - LARYNGOSCOPE EUDAMED
- Model / Reference
- 38533815 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436041581604 EUDAMED
- Basic UDI-DI
- 84360415816423N EUDAMED
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I 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: Laryngoscope blade, reusable
OPT ø6x70º AUT. Great Magnification by Optomic España S.a — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Laryngoscope blade, reusable.
- Xenamed Industries — Xenamed Industries · Class I
- WL Economy Macintosh blade, no. 2, socle blue — Kirchner & Wilhelm GmbH + Co KG · Class I
- Carnegie Surgical LLC — Carnegie Surgical LLC · Class I
- Laryngoscope Lunalite 'D' Mac Blade No.4 — Medical Devices (Pvt) Ltd · Class I
- Diamond Fibrelight Case / Blade (Seward Size 1, Macintosh Size 3, 4), Standard Handle — Penlon Limited · Class I
- Reusable Conventional Blade Wisconsin 4 — FLEXICARE MEDICAL LIMITED · Class I
- Heating Connector for Jet-Laryngoscopes with Mounting Points — CARL REINER GmbH Medizintechnik für Diagnose und Therapie Manufaktur chirurgischer Instrumente · Class IIa
- Sklar® — Sklar Corporation · 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 | 84360415816423N | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Optomic España S.a
- EUDAMED SRN
- ES-MF-000003235
Sources (1)
- EUDAMED 89aa2676-2b4a-4412-96d4-e2203ee7e252 61 fields · synced Jun 19, 2026