EUDAMED last updated this device on May 20, 2026

SE102-8DL20

B-06936260866824

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hicren (Zhejiang) Medtech Co., Ltd.
UDI-DI code: 06936260866824
Reference / catalog number: SE102-8DL20

SE102-8DL20 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Hicren (Zhejiang) Medtech Co., Ltd.. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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EUDAMED last updated this device on May 20, 2026

SE102-8DL20

B-06936260866824

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hicren (Zhejiang) Medtech Co., Ltd.
UDI-DI code: 06936260866824
Reference / catalog number: SE102-8DL20

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 06936260866824
Basic UDI-DI: B-06936260866824
Reference / catalog number: SE102-8DL20
Issuing entity: GS1

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: This product is suitable for grinding bone tissues and soft tissues during an orthopedic surgery.
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)06936260866824

EMDN nomenclature code(s)

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

Z12130585MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES

Critical warnings

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

CW010
Read the instruction carefully.

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06936260866824
Basic UDI-DI: B-06936260866824
Reference / catalog number: SE102-8DL20
Issuing entity: GS1

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: This product is suitable for grinding bone tissues and soft tissues during an orthopedic surgery.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Hicren (Zhejiang) Medtech Co., Ltd.
SRN: CN-MF-000025999
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06936260866824

EMDN nomenclature code(s)

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

Z12130585MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES

Critical warnings

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

CW010
Read the instruction carefully.

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

Certificates

Certificate health across this manufacturer's portfolio.

HZ 2138909-1Amended
Quality management systemNotified body: 0197Expiry: Dec 17, 2029

Legacy certificates

Certificate number: M.2020.106.13865
Type: MDD Annex II (excl. §4)
Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (2292)
Validity: Dec 31, 2028

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Hicren (Zhejiang) Medtech Co., Ltd.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

SE102-8DL20

SE102-8DL20

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Legacy certificates

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