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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

KYPHOKIT KIRSCHNER GUIDE — Class IIa MDR by BIOPSYBELL SRL

MD Atlas
BIOPSYBELL SRL

EUDAMED last updated this device on Mar 3, 2026

KYPHOKIT KIRSCHNER GUIDE

8033860KYPFT05A9T

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOPSYBELL SRL
UDI-DI code: 08033860025922
Reference / catalog number: KK11-FGP

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View device family (Basic UDI)

Manufacturer information

Organization name: BIOPSYBELL SRL
SRN: IT-MF-000011601
Manufacturer status: Active

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KYPHOKIT BALLOON CATHETERB-08033860040284On the market RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIPB-08033860024536On the market VerteStable ® cannula with plastic handleB-08033860039011On the market SBTR1613ECB-08033860012557On the market ADIPO-STEM DUOB-08033860037345On the market

Certificates

Certificate health across this manufacturer's portfolio.

IT349638Issued
Quality assuranceNotified body: 1370Expiry: Feb 9, 2030

Critical warnings

5 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.
CW001
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
EL		Still on market
Slovenia		Still on market

Device identification

Trade name: KYPHOKIT KIRSCHNER GUIDE
UDI-DI code: 08033860025922
Basic UDI-DI: 8033860KYPFT05A9T
Reference / catalog number: KK11-FGP
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: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08033860025922

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

K010301SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON

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

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