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Organization name
UDI-DI code
Reference / catalog number

H.ROS STAPLE — Class IIb MDR by SURGIVAL CO., S.A.U.

MD Atlas
SURGIVAL CO., S.A.U.

EUDAMED last updated this device on Apr 29, 2026

H.ROS STAPLE

84352258IMP30600044E

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SURGIVAL CO., S.A.U.
UDI-DI code: 08435225818802
Reference / catalog number: C6102004

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Manufacturer information

Organization name: SURGIVAL CO., S.A.U.
SRN: ES-MF-000028629
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 3 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Italy		Still on market
Portugal		Still on market

Device identification

Trade name: H.ROS STAPLE
UDI-DI code: 08435225818802
Basic UDI-DI: 84352258IMP30600044E
Reference / catalog number: C6102004
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://eifu.surgival.com/
Clinical sizes: 2 MU50
18 MU50
Width between points — 27 MU50
Effective Width — 25 MU50

EMDN nomenclature code(s)

P09120101OSTEOSYNTHESIS STAPLES

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

Related devices

AMERICAN STAPLE FOR LIGAMENTS84352258IMP306000148On the market AMERICAN STAPLE FOR LIGAMENTS84352258IMP306000148On the market AMERICAN STAPLE FOR LIGAMENTS84352258IMP306000148On the market AMERICAN STAPLE FOR LIGAMENTS84352258IMP306000148On the market AMERICAN STAPLE FOR LIGAMENTS WITHOUT SPIKES84352258IMP306000148On the market

Certificates

Certificate health across this manufacturer's portfolio.

2024 CR 0015Supplemented
Quality management systemNotified body: 0318Expiry: Feb 5, 2029