REGOLATORE di TENUTA CAPPETTE NORMO

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 080RCN

by Rhein 83 S.r.l.

Identity

Trade Name: REGOLATORE di TENUTA CAPPETTE NORMO EUDAMED
DENTAL ATTACHMENTS FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: Strumenti (Regola 1) EUDAMED
STERILIZABLE device with stainless steel tip and aluminium handle FDA UDI
Model / Reference: 080RCN EUDAMED
REAMER x REGULATING CAPS STANDARD size FDA UDI
Description: STERILIZABLE device with stainless steel tip and aluminium handle FDA UDI

Identifiers

Catalog Number: 080RCN FDA UDI
Primary DI / UDI-DI: 08059224000022 EUDAMEDFDA UDI
Basic UDI-DI: 805804571STRPB EUDAMED
FDA Product Code: NDP FDA UDI
EMDN Code: Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.3980 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

REGOLATORE di TENUTA CAPPETTE NORMO by Rhein 83 S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	805804571STRPB	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Rhein 83 S.r.l.
EUDAMED SRN: IT-MF-000005998

Sources (2)

EUDAMED af8c8937-f968-4236-89b1-3097c06a8064 61 fields · synced Oct 6, 2026
FDA UDI 80c724c0-bc1e-432b-8977-7898e163ad7b 34 fields · synced May 30, 2026