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Organization name
UDI-DI code
Reference / catalog number

4400641 — Class I MDR by Haag-Streit AG

MD Atlas
Haag-Streit AG

EUDAMED last updated this device on Feb 14, 2025

4400641

764013298NEO900_CapsKK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Haag-Streit AG
UDI-DI code: 07640132989120
Reference / catalog number: 4400641

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Manufacturer information

Organization name: Haag-Streit AG
SRN: CH-MF-000020981
Manufacturer status: Active

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4000058764013298NEO900_CamAttMNOn the market 4000059764013298NEO900_CamAttMNOn the market 1420180B-07640132985979On the market 1420157B-07640132986907On the market 1420156B-07640132986044On the market

Market distribution

Primary placement in Bulgaria; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07640132989120
Basic UDI-DI: 764013298NEO900_CapsKK
Reference / catalog number: 4400641
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: Cap 12D x 19 Sterilizable for fine adjustment of red reflex Enhancer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1201118099INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - OTHER

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.

170775963Issued
Quality management systemNotified body: 0297Expiry: Jul 6, 2027
170775962Issued
Technical documentationNotified body: 0297Expiry: Jul 6, 2027