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PureRegen Gel Sinus

EUDAMED

Class IIa (EU MDR)

Ref 40-011-005Model I-2ml, I-5ml, I-6ml, I-8ml, I-10ml, I-20ml, II-2ml, II-5ml, II-6ml, II-8ml, II-10ml, II-20mlModel II-5ml

by BioRegen Biomedical (Changzhou) Co., Ltd.

Identity

Trade Name
PureRegen Gel Sinus EUDAMED
Device Name
Nasal and Sinus Dressing EUDAMED
Model / Reference
I-2ml, I-5ml, I-6ml, I-8ml, I-10ml, I-20ml, II-2ml, II-5ml, II-6ml, II-8ml, II-10ml, II-20ml EUDAMED
40-011-005 EUDAMED
II-5ml EUDAMED

Identifiers

Primary DI / UDI-DI
06952181200202 EUDAMED
Basic UDI-DI
69521812400044A EUDAMED
B-06952181200202 EUDAMED
EMDN Code
M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

PureRegen Gel Sinus by BioRegen Biomedical (Changzhou) Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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Manufacturer

Manufacturer
BioRegen Biomedical (Changzhou) Co., Ltd.
EUDAMED SRN
CN-MF-000007975
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED b21db5f3-abba-4b22-820d-8296491745f0 61 fields · synced Oct 6, 2026
  • EUDAMED a0bec93b-f2dd-4a74-ae16-2d517f678b5b 61 fields · synced May 19, 2026