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CN-MF-000012943G2S 1804 91657 012Single Use Anoscope Kit for CPH is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Suzhou Frankenman Medical Equipment Co.,Ltd. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 27, 2026
B-06933816803678Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06933816803678
1 warning recorded — scroll inside the panel to see all entries.
CW999Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Austria; available across 14 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Latvia | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Slovakia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06933816803678Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-06933816803678CK34MUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
H020280STAPLERS FOR OPEN SURGERY - ACCESSORIESNo certificate specifically references this device's Basic UDI-DI.
B-06933816803692On the marketSingle Use Anoscope Kit for CPHB-06933816803685On the marketSingle Use Anoscope Kit for CPHB-06933816803661On the marketSingle Use Curved Intraluminal Circular StaplerB-06933816800271On the marketSingle Use Curved Intraluminal Circular StaplerB-06933816800264On the marketSingle Use Curved Intraluminal Circular StaplerB-06933816804279On the marketCertificate health across this manufacturer's portfolio.
G15 091657 0022SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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