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Laryngoscope Macintosh blade
EUDAMEDClass I (EU MDR)
Ref AI-5101, AI-5102, AI-5103, AI-5104, AI-5106, AI-5107
Identity
- Trade Name
- Laryngoscope Macintosh blade EUDAMED
- Device Name
- Laryngoscope Macintosh blade size 00, 0, 1, 2, 3, 4, 5 Conventional Reusable EUDAMED
- Model / Reference
- AI-5101, AI-5102, AI-5103, AI-5104, AI-5106, AI-5107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003079017 EUDAMED
- Basic UDI-DI
- 8964003079AI5101YR EUDAMED
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Laryngoscope Macintosh blade by Azwan Industries — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Laryngoscope blade, reusable.
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- 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 | 8964003079AI5101YR | Class I | Active |
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Manufacturer
- Manufacturer
- Azwan Industries
- EUDAMED SRN
- PK-MF-000030278
- Authorised Representative
- Yellow's medical instruments GmbH DE-AR-000007390
Sources (2)
- EUDAMED f6c783ab-0963-4e42-8981-4a55fb5ec031 61 fields · synced Jun 19, 2026
- EUDAMED f6c783ab-0963-4e42-8981-4a55fb5ec031-1 61 fields · synced Jun 10, 2026