Identity
- Trade Name
- Sugi EUDAMEDFDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- Sugi Eyespear (pointed tip), rectangular white handle, sterile, 20 x 10 pcs. EUDAMEDSugi Eyespear (pointed tip) 17x7mm,sterile,20 x 10 pcs. FDA UDI
- Model / Reference
- 30601 EUDAMEDFDA UDI
- Description
- Sugi Eyespear (pointed tip) 17x7mm,sterile,20 x 10 pcs. FDA UDI
Identifiers
- Catalog Number
- 30601 FDA UDI
- Primary DI / UDI-DI
- 04260306710027 EUDAMEDFDA UDI
- Basic UDI-DI
- 426030671OPHT8M EUDAMED
- FDA Product Code
- HOZ FDA UDI
- EMDN Code
- M040299 NON-ADHESIVE ABSORBENT DRESSINGS - OTHER EUDAMED
- GMDN Term
- Ophthalmic sponge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4790 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sugi by QUESTALPHA GmbH & Co. KG — Class IIa — 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 | 426030671OPHT8M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- QUESTALPHA GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005033
Sources (2)
- EUDAMED 87438342-e3ab-4819-ace9-d8677ea4f794 61 fields · synced Jul 18, 2026
- FDA UDI 1b2c7439-207c-4b5e-9662-439d37cde151 35 fields · synced May 30, 2026