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Zeitels Angled European Horizontal Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref HHA-EURO
Identity
- Trade Name
- Endocraft LLC FDA UDI
- Generic Name
- Laryngoscope handle, reusable FDA UDI
- Device Name
- Zeitels Angled European Horizontal Handle EUDAMEDEuropean Angled Horizontal Handle Assembly for use with Storz-stlye scopes to connect to Suspension Gallows FDA UDI
- Model / Reference
- HHA-EURO EUDAMEDFDA UDI
- Description
- European Angled Horizontal Handle Assembly for use with Storz-stlye scopes to connect to Suspension Gallows FDA UDI
Identifiers
- Catalog Number
- HHA-EURO FDA UDI
- Primary DI / UDI-DI
- 00860009975118 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600099751HHAEUROES 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
Zeitels Angled European Horizontal Handle by Endocraft LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08600099751HHAEUROES | 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 71c8ec31-229f-498e-a2fc-108491d80c05 61 fields · synced Aug 3, 2026
- FDA UDI 6cce7178-a0ed-41da-9729-4796b0aa6540 35 fields · synced May 30, 2026