Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

HANEL Shimstock foil 8 µ 8mm x 5m… — Class I MDR

MD Atlas
Coltène/Whaledent GmbH + Co. KG

EUDAMED last updated this device on Dec 8, 2025

HANEL Shimstock foil 8 µ 8mm x 5m no colour

++E165TAU1SHIM4001SX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Coltène/Whaledent GmbH + Co. KG
UDI-DI code: 04260538379764
Reference / catalog number: 480180

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Coltène/Whaledent GmbH + Co. KG
SRN: DE-MF-000005717
Manufacturer status: Active

Related devices

Dental rolls ROEKO Cotton-roll #1 1000pcs++E165TAU1CORO4001RHOn the market Dental rolls ROEKO Cotton-roll #2 1000pcs++E165TAU1CORO4001RHOn the market Dental rolls ROEKO Cotton-roll #3 1000pcs++E165TAU1CORO4001RHOn the market Dental rolls ROEKO Luna #1 1000pcs++E165TAU1LUNA4001TLOn the market Dental rolls ROEKO Luna #1 300g++E165TAU1LUNA4001TLOn the market

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.

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: HANEL Shimstock foil 8 µ 8mm x 5m no colour
UDI-DI code: 04260538379764
Basic UDI-DI: ++E165TAU1SHIM4001SX
Reference / catalog number: 480180
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 8 MU43
8 MU50
5 MU36

EMDN nomenclature code(s)

Q01020299DENTAL CONTACT INDICATORS - OTHER

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification