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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

PolyPhil hair — Class III MDD by Mastelli S.r.l.

MD Atlas
Mastelli S.r.l.

EUDAMED last updated this device on Apr 7, 2025

PolyPhil hair

B-8053303261618DDM21GH

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Mastelli S.r.l.
UDI-DI code: D-8053303261618DDM21GH
Reference / catalog number: DDM21HBL20WE1

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Manufacturer information

Organization name: Mastelli S.r.l.
SRN: IT-MF-000023613
Manufacturer status: Active

Critical warnings

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

CW275
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW030
EUDAMED did not publish a description for this code.
CW267
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW136
EUDAMED did not publish a description for this code.
CW166
EUDAMED did not publish a description for this code.
CW999
Do not use other products during the same treatment session with Polyphil hair.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2007	Still on market

Device identification

Trade name: PolyPhil hair
UDI-DI code: D-8053303261618DDM21GH
Basic UDI-DI: B-8053303261618DDM21GH
Reference / catalog number: DDM21HBL20WE1
Issuing entity: EUDAMED

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Polyphil hair is a viscoelastic, non-pyrogenic, sterile, single-use Polynucleotide gel for intradermal use. Polynucleotides are highly purified, resorbable and natural substances derived from fish.
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

D-8053303261618DDM21GH

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.