Identity
- Trade Name
- Malyugin Ring System EUDAMEDMalyugin Ring System 7.0mm FDA UDI
- Generic Name
- Intraocular retractor, single-use FDA UDI
- Device Name
- Malyugin Ring System 7.0mm EUDAMED
- Model / Reference
- MAL-0002 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- MAL-0002 FDA UDI
- Primary DI / UDI-DI
- 10844685000040 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10844685000040 EUDAMED
- FDA Product Code
- HOC FDA UDI
- EMDN Code
- Q021106 OPHTHALMIC SURGERY DILATORS, SINGLE-USE EUDAMED
- GMDN Term
- Intraocular retractor, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Malyugin Ring System by Microsurgical Technology, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10844685000040 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MicroSurgical Technology Inc.
- EUDAMED SRN
- US-MF-000020475
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 9b4002ed-483c-4ff1-a8b6-b6d07e576413 61 fields · synced May 30, 2026
- FDA UDI 7febb318-15a9-4f2f-94ef-0930bfebc445 33 fields · synced May 30, 2026