Identity
- Trade Name
- [Kratz] Eye Speculum, adult, open blades EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Eyelid speculum, single-use FDA UDI
- Device Name
- EYE SPECULUM (ADULT) [KRATZ] FDA UDI
- Model / Reference
- 8402 EUDAMEDFDA UDISpeculum EUDAMED
- Description
- EYE SPECULUM (ADULT) [KRATZ] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516138503 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840516184006D EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Eyelid speculum, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eyelid speculum, single-use
Anodyne Surgical by Psi/Eye-Ko, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Psi/Eye-Ko, Inc.
Sources (2)
- FDA UDI a524852d-ea3a-4569-8ff5-8297682f6971 34 fields · synced Jun 19, 2026
- EUDAMED 705cec37-31ce-4801-bec0-da2a6698c81e 61 fields · synced Jun 19, 2026