← Back to catalogue

Advanced Markus

FDA UDI

Class II (US FDA UDI)

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Identity

Trade Name
Advanced Markus FDA UDI
Generic Name
Ionization chamber radiation measuring probe FDA UDI
Model / Reference
Advanced Markus electron chamber 0.02 cm³ FDA UDI

Identifiers

Catalog Number
TB34045 FDA UDI
Primary DI / UDI-DI
EPTWTB340450 FDA UDI
510(k) Number
K961208 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Ionization chamber radiation measuring probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ionization chamber radiation measuring probe

Advanced Markus by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ionization chamber radiation measuring probe.

Cleared under the same submission

K961208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Sources (1)

  • FDA UDI 17b03408-65de-43a9-a168-541fe2ba10a6 34 fields · synced Jun 9, 2026