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Organization name
UDI-DI code
Reference / catalog number

316N — Class IIa MDR by Ortopedia y Cirugía, S.L.

MD Atlas
Ortopedia y Cirugía, S.L.

EUDAMED last updated this device on Apr 28, 2026

316N

84350815CCEEN2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ortopedia y Cirugía, S.L.
UDI-DI code: 08435081503164
Reference / catalog number: 316N

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Manufacturer information

Organization name: Ortopedia y Cirugía, S.L.
SRN: ES-MF-000016977
Manufacturer status: Active

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4838428843508154838F3On the market 4838671843508154838F3On the market 4838596843508154838F3On the market 4515183843508159700F8On the market 4514926843508159700F8On the market

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW007
No utilizar si el envase individual está deteriorado
CW009
Producto de un solo uso

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Apr 28, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435081503164
Basic UDI-DI: 84350815CCEEN2
Reference / catalog number: 316N
Issuing entity: GS1

Classification

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

Device details

Quantity: 5
Additional product description: SOBRE 5 COMP. 45X45 17H 4T RX
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M0201030201LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE

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.

2024 PR 0016Issued
Quality assuranceNotified body: 0318Expiry: Feb 18, 2029