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Slim Zeitels Universal Modular Glottiscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref SlimUMG100
Identity
- Trade Name
- Endocraft LLC FDA UDI
- Generic Name
- Laryngoscope handle, reusable FDA UDI
- Device Name
- Slim Zeitels Universal Modular Glottiscope EUDAMEDZeitels Slim Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This product contains 3 blades of different sizes and one handle. Also included is a suction Cannula, a light carrier, and a fiberoptic light cable. It is slimmer and designed geometrically to enhance access to tighter surgical sites. FDA UDI
- Model / Reference
- SlimUMG100 EUDAMEDFDA UDI
- Description
- Zeitels Slim Universal Modular Glottiscope System is a Modular Laryngoscope for Vocal surgery. This product contains 3 blades of different sizes and one handle. Also included is a suction Cannula, a light carrier, and a fiberoptic light cable. It is slimmer and designed geometrically to enhance access to tighter surgical sites. FDA UDI
Identifiers
- Catalog Number
- SlimUMG100 FDA UDI
- Primary DI / UDI-DI
- 00860009975101 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600099751UMGWA EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Laryngoscope handle, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laryngoscope blade, reusable
Slim Zeitels Universal Modular Glottiscope by Endocraft LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600099751UMGWA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Endocraft LLC
- EUDAMED SRN
- US-MF-000020169
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 5ffd4e06-f584-4300-bb3c-e042082e7b72 61 fields · synced Jul 12, 2026
- FDA UDI 2dc80115-e80d-4631-8a58-8771f329f164 35 fields · synced May 30, 2026