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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

CIE01 — Class IIa MDD by Schwabe Pharma Italia

MD Atlas
Schwabe Pharma Italia

EUDAMED last updated this device on May 22, 2026

CIE01

B-CIE01U2

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Schwabe Pharma Italia
UDI-DI code: D-CIE01U2
Reference / catalog number: CIE01

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View device family (Basic UDI)

Manufacturer information

Organization name: Schwabe Pharma Italia
SRN: IT-MF-000029129
Manufacturer status: Active

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CNP01B-CNP01WUOn the market CNP02B-CNP02WWOn the market CNP03B-CNP03WYOn the market KG02B-KG02J7On the market KG03B-KG03J9On the market

Certificates

Certificate health across this manufacturer's portfolio.

ITD 1342965 1Amended
Quality assuranceNotified body: 1936Expiry: Apr 9, 2028

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2021	Oct 31, 2026

Device identification

Trade name: not provided
UDI-DI code: D-CIE01U2
Basic UDI-DI: B-CIE01U2
Reference / catalog number: CIE01
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: Vaginal idrogel
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-CIE01U2

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.

U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

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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