EUDAMED last updated this device on Jul 9, 2026

Silicone Reservoir

69449327FN01E01HV

On the marketClass I

Applicable legislation: —
Organization name: Well Lead Medical Co., Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06936881168796
Reference / catalog number: N01E011510

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Silicone Reservoir is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Well Lead Medical Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Silicone Reservoir
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06936881168796
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 69449327FN01E01HV
Reference / catalog number: N01E011510
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The Silicone Reservoir is made of medical grade silicone. Accessories for the Silicone Reservoir include: Connector with Tube. The product can be connected to the drainage tube and used on patient who needs body fluid drainage.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Silicone drainage jar150mL

Packaging levels

1 packaging level registered — each level carries its own UDI-DI.

06936881168796× 1 unitBase unit
- 26936881168790× 50 units

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06936881168796

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

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

A060301COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 27 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market

Related searches

Class I medical devices in EUDAMED

Device identification

Trade name: Silicone Reservoir
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06936881168796
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 69449327FN01E01HV
Reference / catalog number: N01E011510
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Device details

Quantity: 1
Additional product description: The Silicone Reservoir is made of medical grade silicone. Accessories for the Silicone Reservoir include: Connector with Tube. The product can be connected to the drainage tube and used on patient who needs body fluid drainage.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Silicone drainage jar150mL

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Germany; available across 27 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Czechia	—	Still on market
Denmark	—	Still on market
Estonia	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Finland	—	Still on market
France	—	Still on market
Croatia	—	Still on market
Hungary	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Lithuania	—	Still on market
Luxembourg	—	Still on market
Latvia	—	Still on market
Malta	—	Still on market
Netherlands	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Romania	—	Still on market
Sweden	—	Still on market
Slovenia	—	Still on market
Slovakia	—	Still on market

Silicone Reservoir

Device identification

Classification

Device details

Packaging levels

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Packaging levels

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

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