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

12000-D05 — Class I MDD by SPIGGLE & THEIS…

MD Atlas
SPIGGLE & THEIS Medizintechnik GmbH

EUDAMED last updated this device on Jun 27, 2023

12000-D05

B-04250381804346

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SPIGGLE & THEIS Medizintechnik GmbH
UDI-DI code: 04250381804346
Reference / catalog number: 12000-D05

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: SPIGGLE & THEIS Medizintechnik GmbH
SRN: DE-MF-000006647
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04250381804346
Basic UDI-DI: B-04250381804346
Reference / catalog number: 12000-D05
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P020180OTOLOGIC PROSTHESES - ACCESSORIES

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

Related devices

Injection needleB-04250381858806On the market Injection needleB-04250381858813On the market 3010040B-04250676706157On the market 3010030B-04250676706140On the market 11000-D75B-04250381803721On 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.