Identity
- Trade Name
- SUF01 Koch Manipulator Sterile EUDAMED
- Device Name
- Manipulators, single-use EUDAMED
- Model / Reference
- SUF01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24058935005102 EUDAMED
- Basic UDI-DI
- 4058935-100000-AV EUDAMED
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Ophthalmic surgical probe, single-use
SUF01 Koch Manipulator Sterile by Bausch & Lomb GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, single-use.
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- HASA OPTIX — Hasa Optix · Class IIa
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- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- Epithelial Spatula — BLINK MEDICAL LIMITED · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4058935-100000-AV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED 9195e46e-44e0-4b9e-9dbe-a996768e5e87 61 fields · synced Jun 18, 2026