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Organization name
UDI-DI code
Reference / catalog number

55350 Capsule Spatula — Class I MDR by Bausch & Lomb GmbH

MD Atlas
Bausch & Lomb GmbH

EUDAMED last updated this device on Mar 19, 2026

55350 Capsule Spatula

4058935-000000-AC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bausch & Lomb GmbH
UDI-DI code: 04058935007867
Reference / catalog number: 55350

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Manufacturer information

Organization name: Bausch & Lomb GmbH
SRN: DE-MF-000009142
Manufacturer status: Active

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: 55350 Capsule Spatula
UDI-DI code: 04058935007867
Basic UDI-DI: 4058935-000000-AC
Reference / catalog number: 55350
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L1706OPHTHALMOLOGY SPATULAS, REUSABLE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

HZ 2520883-1Supplemented
Quality management systemNotified body: 0197Expiry: Apr 26, 2028
HZ 1333770-1Issued
Quality management systemNotified body: 0197Expiry: Apr 26, 2028